| 1 |
NCT03619967 |
Recruiting |
Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers |
|
- Device: Multispectral imager
|
Interventional
|
Not Applicable |
- University of Illinois at Urbana-Champaign
- Ss. Cyril and Methodius University of Skopje, Macedonia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
|
10 |
Female |
17 Years to 80 Years (Child, Adult, Older Adult) |
NCT03619967 |
18947 |
|
July 20, 2018 |
July 2019 |
October 2019 |
August 8, 2018 |
August 8, 2018 |
|
- University Clinic Hospital
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 2 |
NCT02620566 |
Completed |
Caudal Block vs Local Wound Infiltration for Hernia Repair in Children |
|
- Procedure: Bupivacain- Caudal
- Procedure: Bupivacaine- Local
|
Interventional
|
Phase 1
Phase 2 |
- University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to First Analgesic Requirement
- The total number of oral acetaminophen
|
80 |
All |
6 Months to 7 Years (Child) |
NCT02620566 |
UCTOARICED1 |
CBvsLWI |
September 2015 |
December 2015 |
December 2015 |
December 3, 2015 |
January 5, 2016 |
|
- Uctoariced
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 3 |
NCT01730456 |
Completed |
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926 |
|
- Drug: tocilizumab [RoActemra/Actemra]
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Long-term safety: Incidence of adverse events
- Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)
- Change in total tender joint count (TJC) / swollen joint count (SJC)
- (and 2 more...)
|
13 |
All |
18 Years and older (Adult, Older Adult) |
NCT01730456 |
ML28133 |
|
October 2012 |
May 2015 |
May 2015 |
November 21, 2012 |
November 2, 2016 |
|
- Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 4 |
NCT01684865 |
Completed |
An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants With Adverse Events
- Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
- Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
- (and 5 more...)
|
22 |
All |
18 Years and older (Adult, Older Adult) |
NCT01684865 |
ML27993 |
|
October 22, 2012 |
November 27, 2017 |
November 27, 2017 |
September 13, 2012 |
December 29, 2017 |
|
- University Clinic of Hematology Skopje, Hospital Care Department
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 5 |
NCT01542424 |
Completed |
An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus |
- Diabetes
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
|
- Drug: biphasic insulin aspart 30
- Drug: insulin detemir
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- HbA1c (glycosylated haemoglobin)
- Percentage of subjects reaching HbA1c target of maximum 7.0%
- Postprandial plasma glucose (PPG)
- (and 3 more...)
|
1889 |
All |
Child, Adult, Older Adult |
NCT01542424 |
NN304-1763 |
|
March 2006 |
December 2006 |
December 2006 |
March 2, 2012 |
January 31, 2017 |
|
- Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 6 |
NCT00842894 |
Completed |
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia |
- Diabetes
- Diabetes Mellitus, Type 2
|
- Drug: insulin detemir
- Drug: biphasic insulin aspart 30
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of serious adverse drug reactions (SADRs)
- Number of all minor hypoglycaemic events
- Number of all major hypoglycaemic events
- (and 5 more...)
|
3421 |
All |
Child, Adult, Older Adult |
NCT00842894 |
NN304-3716 |
|
May 2009 |
October 2010 |
October 2010 |
February 12, 2009 |
August 15, 2014 |
|
- Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 7 |
NCT00665093 |
Completed |
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
|
- Drug: biphasic insulin aspart 30
- Drug: insulin detemir
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- HbA1c
- FPG, PG profile, weight, % of subjects on target
|
1569 |
All |
Child, Adult, Older Adult |
NCT00665093 |
BIASP-1894 |
|
May 2007 |
January 2008 |
January 2008 |
April 23, 2008 |
January 9, 2017 |
|
- Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 8 |
NCT00412139 |
Completed |
Serum Uremic Toxins and Histological Findings of the Blood Vessels in Dialysis Patients |
|
|
Observational
|
|
- University of Skopje
- Ministry of Science and Education, R. Macedonia
|
Other |
- Observational Model: Case-Crossover
- Time Perspective: Prospective
|
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00412139 |
13-1001/2-05 |
|
December 2006 |
November 2008 |
January 2010 |
December 15, 2006 |
February 9, 2010 |
|
- Department of Nephrology, University Clinical Center
Skopje, Macedonia, The Former Yugoslav Republic of
|
|
| 9 |
NCT03552250 |
Completed |
Prevention of Child Mental Health Problems in Southeastern Europe |
|
- Behavioral: Parenting for Lifelong Health for Young Children
|
Interventional
|
Not Applicable |
- Technische Universitaet Braunschweig
- Alpen-Adria-University Klagenfurt
- University of Oxford
- (and 6 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale
- Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated
- Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale
- (and 7 more...)
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT03552250 |
H2020-779318
H2020-SC1-2017-RTD-779318 |
RISE |
April 26, 2018 |
November 19, 2018 |
December 2, 2018 |
June 11, 2018 |
December 4, 2018 |
|
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje, Macedonia, The Former Yugoslav Republic of - Health For Youth Association
Chisinau, Moldova, Republic of - Babes Boylai University
Cluj-Napoca, Romania
|
|
| 10 |
NCT00836043 |
Terminated |
Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia |
- Chronic Lymphocytic Leukemia
|
- Drug: Alemtuzumab (MabCampath)
|
Observational
|
|
- Genzyme, a Sanofi Company
- Sanofi
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
|
6 |
All |
18 Years and older (Adult, Older Adult) |
NCT00836043 |
13418
13858
14241
MC0701
STAR |
|
October 2008 |
April 2009 |
April 2009 |
February 4, 2009 |
December 3, 2013 |
|
- Many Locations, Bosnia and Herzegovina
- Many Locations, Israel
- Many Locations, Macedonia, The Former Yugoslav Republic of
|
|
| 11 |
NCT02663323 |
Active, not recruiting |
Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System |
|
- Device: MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
|
Interventional
|
Not Applicable |
- Meril Life Sciences Pvt. Ltd.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure.
- Primary Safety Endpoint: Proportion of population reporting with Ischemia Driven Major Adverse Cardiac Event (ID MACE) reporting at 6 months (180 days) from the day of index procedure
|
64 |
All |
18 Years and older (Adult, Older Adult) |
NCT02663323 |
MER/EX |
MeRes-1Extend |
February 2, 2016 |
October 5, 2017 |
July 5, 2020 |
January 26, 2016 |
August 17, 2018 |
|
- Instituto Dante Pazzanese de Cardiologia
Sao Paulo, SP, Brazil - Medistra Hospital
Jakarta, Indonesia - University Clinic of Cardiology
Skopje, Macedonia, The Former Yugoslav Republic of - Institut Jantung Negara
Kuala Lumpur, Malaysia
|
|
| 12 |
NCT01422824 |
Completed
Has Results |
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis |
- Anemia, Kidney Disease, Chronic
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of Participants With Adverse Events (AEs)
- Hemoglobin Levels
|
185 |
All |
18 Years and older (Adult, Older Adult) |
NCT01422824 |
ML25067 |
|
June 2010 |
January 2014 |
January 2014 |
August 24, 2011 |
March 28, 2016 |
March 28, 2016 |
- Delcevo, Macedonia, The Former Yugoslav Republic of
- Prilep, Macedonia, The Former Yugoslav Republic of
- Skopje, Macedonia, The Former Yugoslav Republic of
- (and 3 more...)
|
|
| 13 |
NCT00447382 |
Completed
Has Results |
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 1
|
- Drug: insulin detemir
- Drug: insulin aspart
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
- Hypoglycaemic Episodes
- Glycaemic Control Parameters (Change in HbA1c)
- (and 21 more...)
|
330 |
All |
18 Years and older (Adult, Older Adult) |
NCT00447382 |
EX1729-1778
2006-004733-15 |
|
March 2007 |
July 2008 |
July 2008 |
March 14, 2007 |
October 9, 2014 |
May 12, 2011 |
- Belgrade, Former Serbia and Montenegro
- Frankfurt, Germany
- Skopje, Macedonia, The Former Yugoslav Republic of
- (and 2 more...)
|
|
| 14 |
NCT02111564 |
Completed |
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients |
- Heart Failure
- Respiratory Insufficiency
- Stroke Acute
- (and 2 more...)
|
- Drug: Rivaroxaban, 10 mg
- Drug: Rivaroxaban, 7.5 mg
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
- Bayer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- Time from randomization to the first occurrence of symptomatic venous thromboembolism event (VTE) and VTE-related death
- Time from randomization to the first occurrence of major bleeding
- Time from randomization to an occurrence of VTE-related death
- (and 4 more...)
|
12025 |
All |
40 Years and older (Adult, Older Adult) |
NCT02111564 |
CR103834
2014-000305-13
RIVAROXDVT3002 |
MARINER |
January 7, 2014 |
May 3, 2018 |
May 3, 2018 |
April 11, 2014 |
October 15, 2018 |
|
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Sheffield, Alabama, United States
- (and 614 more...)
|
|
| 15 |
NCT01578785 |
Terminated
Has Results |
An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) |
- Relapsing-Remitting Multiple Sclerosis
|
- Drug: Glatiramer Acetate
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The Annualized Relapse Rate During the Placebo Controlled Period
- The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)
- The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)
- Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume
|
178 |
All |
18 Years to 55 Years (Adult) |
NCT01578785 |
GA-MS-302
2011-005550-57 |
GLOW |
March 2012 |
October 2012 |
November 2012 |
April 17, 2012 |
April 2, 2014 |
April 2, 2014 |
- Teva Investigational Site 10192
Cullman, Alabama, United States - Teva Investigational Site 10204
Fresno, California, United States - Teva Investigational Site 10201
La Jolla, California, United States - (and 166 more...)
|
|
| 16 |
NCT01313676 |
Completed
Has Results |
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease |
- Pulmonary Disease, Chronic Obstructive
|
- Drug: fluticasone furoate/vilanterol
- Drug: fluticasone furoate
- Drug: vilanterol
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date
- Decline in Forced Expiratory Volume in 1 Second (FEV1)
- Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
|
16568 |
All |
40 Years to 80 Years (Adult, Older Adult) |
NCT01313676 |
113782 |
|
January 25, 2011 |
July 15, 2015 |
July 15, 2015 |
March 14, 2011 |
August 6, 2018 |
August 9, 2016 |
- GSK Investigational Site
Andalusia, Alabama, United States - GSK Investigational Site
Athens, Alabama, United States - GSK Investigational Site
Birmingham, Alabama, United States - (and 1618 more...)
|
|
| 17 |
NCT03315143 |
Recruiting |
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk |
- Type 2 Diabetes Mellitus
- Chronic Kidney Diseases
|
- Drug: Sotagliflozin (SAR439954)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time to first Major Adverse Cardiovascular Event (MACE)
- Time to cardiovascular death or hospitalization for heart failure
- Time to first composite renal event
- (and 4 more...)
|
10500 |
All |
18 Years and older (Adult, Older Adult) |
NCT03315143 |
EFC14875
2017-002644-32
U1111-1187-8703 |
SCORED |
November 28, 2017 |
March 2022 |
March 2022 |
October 19, 2017 |
January 14, 2019 |
|
- Investigational Site Number 8400017
Birmingham, Alabama, United States - Investigational Site Number 8400096
Sheffield, Alabama, United States - Investigational Site Number 8400004
Mesa, Arizona, United States - (and 674 more...)
|
|
| 18 |
NCT01663402 |
Completed |
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab |
|
- Drug: alirocumab
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization
- Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality
- Change from baseline in blood lipids and lipoprotein levels
|
18600 |
All |
40 Years and older (Adult, Older Adult) |
NCT01663402 |
EFC11570
2011-005698-21
U1111-1127-4323 |
|
October 2012 |
January 23, 2018 |
January 23, 2018 |
August 13, 2012 |
February 14, 2018 |
|
- Investigational Site Number 840163
Birmingham, Alabama, United States - Investigational Site Number 840060
Birmingham, Alabama, United States - Investigational Site Number 840117
Huntsville, Alabama, United States - (and 1385 more...)
|
|
| 19 |
NCT00632125 |
Completed
Has Results |
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. |
|
- Drug: HX575 recombinant human erythropoietin alfa
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
|
1695 |
All |
18 Years and older (Adult, Older Adult) |
NCT00632125 |
2006-66-INJ-14 |
EPO-PASS |
July 2008 |
March 2010 |
September 2010 |
March 10, 2008 |
July 11, 2017 |
July 11, 2017 |
- Dialysepraxis Dres. Huspek/Schmid
Bad Ischl, Austria - Landeskrankenhaus Feldkirch
Feldkirch, Austria - Landeskrankenhaus Freistadt
Freistadt, Austria - (and 111 more...)
|
|
| 20 |
NCT00525577 |
Unknown † |
ANDES-AGI-1067 as a Novel Antidiabetic Agent Evaluation Study |
|
- Drug: Placebo
- Drug: AGI-1067
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in HbA1c to the 6-month time point is identical in the study groups (placebo and AGI-1067 treatment groups)
- • Change of HbA1c from baseline throughout the study • Change of FPG from baseline throughout the study•
|
1012 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00525577 |
AGI-1067-052 |
ANDES |
August 2007 |
June 2008 |
September 2008 |
September 6, 2007 |
February 6, 2008 |
|
- Clinical Research Atlanta
Stockbridge, Georgia, United States - Diabetes and Glandular Disease
San Antonio, Texas, United States - Clinic for the Internal Medicine-Clinical Center Banja Luka
Banja Luka, Bosnia and Herzegovina - (and 87 more...)
|
|
| 21 |
NCT03337724 |
Recruiting |
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer |
|
- Drug: Ipatasertib
- Drug: Paclitaxel
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- (and 8 more...)
|
450 |
All |
18 Years and older (Adult, Older Adult) |
NCT03337724 |
CO40016
2017-001548-36 |
IPATunity130 |
January 6, 2018 |
December 22, 2021 |
December 22, 2021 |
November 9, 2017 |
January 10, 2019 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States - USC Norris Cancer Center
Los Angeles, California, United States - Kaiser Permanente - Oakland
Oakland, California, United States - (and 217 more...)
|
|
| 22 |
NCT03006770 |
Recruiting |
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization |
- Critical Limb Ischemia (CLI)
|
- Biological: PLX-PAD
- Biological: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to major amputation or death (AFS)
- Time to first occurrence of any of the events (in index leg)-major amputation,revascularization due to worsening of CLI,doubling of total wound area from baseline,anew gangrene. All-cause mortality.
- Time to major amputation of the index leg.
- (and 3 more...)
|
246 |
All |
45 Years to 99 Years (Adult, Older Adult) |
NCT03006770 |
PLX-CLI-03 |
|
May 22, 2017 |
May 2020 |
May 2020 |
December 30, 2016 |
December 20, 2018 |
|
- University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location
Miami, Florida, United States - Tufts Medical Center (TMC) (Tufts-New England Medical Center)
Boston, Massachusetts, United States - Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North.
Worcester, Massachusetts, United States - (and 44 more...)
|
|
| 23 |
NCT01707992 |
Completed |
The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) |
|
- Drug: Laquinimod
- Drug: Matching Placebo
|
Interventional
|
Phase 3 |
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Confirmed Disease Progression (CDP) after at least 3 months in Period 1
- Percent change in brain volume
- The time to first confirmed relapse during Period 1
- (and 2 more...)
|
2199 |
All |
18 Years to 55 Years (Adult) |
NCT01707992 |
LAQ-MS-305 |
CONCERTO |
February 20, 2013 |
April 13, 2015 |
July 4, 2017 |
October 16, 2012 |
May 3, 2018 |
|
- Teva Investigational Site 10329
Cullman, Alabama, United States - Teva Investigational Site 10310
Fresno, California, United States - Teva Investigational Site 10332
Fort Collins, Colorado, United States - (and 206 more...)
|
|
| 24 |
NCT01261494 |
Completed |
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus |
- Type II Diabetes Mellitus
|
- Drug: GFT505 80mg
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- HbA1c
- Oral Glucose Tolerance Test (OGTT)
- Fasting Plasma Glucose
- Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]
|
97 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01261494 |
GFT505-210-5
2010-021986-60 |
|
December 2010 |
June 2011 |
June 2011 |
December 16, 2010 |
July 13, 2011 |
|
- Site n°12
Banja Luka, Bosnia and Herzegovina - Site n°11
Sarajevo, Bosnia and Herzegovina - Site n°22
Riga, Latvia - (and 25 more...)
|
|
| 25 |
NCT01196091 |
Completed
Has Results |
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus |
- Systemic Lupus Erythematosus
- Connective Tissue Disease
- Autoimmune Disease
|
- Drug: LY2127399
- Drug: Placebo every 2 weeks
- Drug: Placebo every 4 weeks
- Drug: Standard of Care
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving an SLE Responder Index Response at Week 52
- Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
- Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
- (and 11 more...)
|
1164 |
All |
18 Years and older (Adult, Older Adult) |
NCT01196091 |
13656
H9B-MC -BCDS |
|
December 2010 |
July 2014 |
June 2015 |
September 8, 2010 |
June 12, 2018 |
June 12, 2018 |
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glendale, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mesa, Arizona, United States - (and 189 more...)
|
|
| 26 |
NCT01047319 |
Terminated
Has Results |
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis |
- Relapsing Multiple Sclerosis
|
|
Interventional
|
Phase 3 |
- Teva Pharmaceutical Industries, Ltd.
- Teva Pharmaceutical Industries
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participants With Treatment-Emergent Adverse Events (TEAEs)
- Participants With Potentially Clinically Significant Abnormal Vital Signs
- Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
- (and 2 more...)
|
1047 |
All |
Child, Adult, Older Adult |
NCT01047319 |
MS-LAQ-302E
2009-015815-42 |
|
May 27, 2010 |
June 30, 2017 |
June 30, 2017 |
January 12, 2010 |
January 9, 2019 |
January 9, 2019 |
- Teva Investigational Site 1267
Homewood, Alabama, United States - Teva Investigational Site 1237
Phoenix, Arizona, United States - Teva Investigational Site 1279
Phoenix, Arizona, United States - (and 141 more...)
|
|
| 27 |
NCT00605215 |
Completed |
BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) |
|
- Drug: laquinimod
- Drug: placebo
- Drug: Interferon β-1a (Avonex®)
|
Interventional
|
Phase 3 |
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assess efficacy, as measured by number of confirmed relapses
- Accumulation of physical disability
- The cumulative number of enhancing lesions on T1-weighted images
- (and 2 more...)
|
1331 |
All |
18 Years to 55 Years (Adult) |
NCT00605215 |
MS-LAQ-302
EUDRACT 2007-005450-23 |
BRAVO |
April 2008 |
November 2011 |
December 2011 |
January 30, 2008 |
August 26, 2013 |
|
- Teva Investigational Site 1267
Birmingham, Alabama, United States - Teva Investigational Site 1237
Phoenix, Arizona, United States - Teva Investigational Site 1279
Phoenix, Arizona, United States - (and 137 more...)
|
|
| 28 |
NCT00567190 |
Completed
Has Results |
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer |
|
- Drug: Pertuzumab
- Drug: Placebo
- Drug: Trastuzumab
- Drug: Docetaxel
|
Interventional
|
Phase 3 |
- Genentech, Inc.
- Hoffmann-La Roche
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS) Determined by an Independent Review Facility
- Overall Survival
- Progression-free Survival (PFS) Determined by the Investigator
- (and 3 more...)
|
808 |
All |
18 Years and older (Adult, Older Adult) |
NCT00567190 |
TOC4129g
WO20698
2007-002997-72 |
CLEOPATRA |
February 12, 2008 |
May 13, 2011 |
November 23, 2018 |
December 4, 2007 |
January 8, 2019 |
September 13, 2012 |
- HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States - NEA Baptist Clinic
Jonesboro, Arkansas, United States - Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States - (and 460 more...)
|
|
| 29 |
NCT03466411 |
Recruiting |
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease |
|
- Drug: Guselkumab Dose 1
- Drug: Guselkumab Dose 2
- Drug: Guselkumab Dose 3
- (and 5 more...)
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
- Phase 3: Clinical Remission at Week 12
- Phase 2: Clinical Remission at Week 12
- (and 10 more...)
|
2000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03466411 |
CR108387
2017-002195-13
CNTO1959CRD3001 |
GALAXI |
April 13, 2018 |
June 3, 2022 |
October 23, 2024 |
March 15, 2018 |
December 28, 2018 |
|
- University of Arizona
Tucson, Arizona, United States - Advanced Research Center Inc
Anaheim, California, United States - University Of California San Diego
La Jolla, California, United States - (and 446 more...)
|
|
| 30 |
NCT03456076 |
Recruiting |
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer |
- Carcinoma, Non-Small-Cell Lung
|
- Drug: Alectnib
- Drug: Cisplatin
- Drug: Vinorelbine
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free Survival (DFS), as Assessed by the Investigator
- Overall Survival (OS)
- Plasma Concentration of Alectinib
- (and 2 more...)
|
255 |
All |
18 Years and older (Adult, Older Adult) |
NCT03456076 |
BO40336
2017-004331-37 |
|
August 16, 2018 |
June 30, 2023 |
September 30, 2026 |
March 7, 2018 |
January 3, 2019 |
|
- Rush University Medical Center
Chicago, Illinois, United States - MGH Cancer Center
Boston, Massachusetts, United States - University of Michigan
Ann Arbor, Michigan, United States - (and 166 more...)
|
|
| 31 |
NCT02978716 |
Active, not recruiting |
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) |
- Triple-Negative Breast Neoplasms
- Breast Neoplasm
- Breast Cancer
- Triple-Negative Breast Cancer
|
- Drug: Trilaciclib
- Drug: Gemcitabine
- Drug: Carboplatin
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
- Tumor response based on RECIST, Version 1.1
- Progression free survival (PFS)
- (and 8 more...)
|
102 |
All |
18 Years and older (Adult, Older Adult) |
NCT02978716 |
G1T28-04
2016-004466-26 |
|
February 7, 2017 |
October 2019 |
February 2020 |
December 1, 2016 |
May 25, 2018 |
|
- Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States - Disney Family Cancer Center
Burbank, California, United States - Sharp Clinical Oncology
San Diego, California, United States - (and 51 more...)
|
|
| 32 |
NCT02518620 |
Completed |
An Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Rheumatoid Arthritis |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects with American College of Rheumatology (ACR) response.
- Change from baseline in disease activity using Disease Activity Score (DAS28, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI).
- Proportion of subjects with European League Against Rheumatism (EULAR) response.
- (and 7 more...)
|
406 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02518620 |
ALX0061-C203
2014-003034-42 |
|
July 2015 |
August 2018 |
August 2018 |
August 10, 2015 |
November 8, 2018 |
|
- Investigator Site
Brussels, Belgium - Investigator Site 2
Brussels, Belgium - Investigator Site
Ghent, Belgium - (and 54 more...)
|
|
| 33 |
NCT02309359 |
Completed |
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis |
|
- Biological: ALX-0061
- Other: Placebo
- Drug: Methotrexate
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of subjects achieving an ACR20 response.
- Proportion of subjects with ACR20, ACR50, and ACR70 response.
- Change from baseline in disease activity using DAS28, SDAI and CDAI.
- (and 9 more...)
|
345 |
All |
18 Years to 74 Years (Adult, Older Adult) |
NCT02309359 |
ALX0061-C201
2014-003033-26 |
|
January 2015 |
August 2016 |
August 2016 |
December 5, 2014 |
September 19, 2017 |
|
- Investigator Site
Birmingham, Alabama, United States - Investigator Site
Hemet, California, United States - Investigator Site
La Palma, California, United States - (and 91 more...)
|
|
| 34 |
NCT02287922 |
Completed |
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis |
|
- Biological: ALX-0061
- Biological: Placebo
- Biological: Tocilizumab
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of subjects with American College of Rheumatology 20 (ACR20)
- Proportion of subjects with ACR20, ACR50, and ACR70 response.
- Change from baseline in disease activity using Disease Activity Score 28 (DAS28), Simplified Disease Activity Index(SDAI) and Clinical Disease Activity Index (CDAI)
- (and 9 more...)
|
251 |
All |
18 Years to 74 Years (Adult, Older Adult) |
NCT02287922 |
ALX0061-C202
2014-003012-36 |
|
March 2015 |
July 2016 |
July 2016 |
November 11, 2014 |
January 4, 2019 |
|
- Investigator Site
Birmingham, Alabama, United States - Investigator Site
Hemet, California, United States - Investigator Site
La Palma, California, United States - (and 80 more...)
|
|
| 35 |
NCT02201108 |
Active, not recruiting |
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis |
|
- Drug: Teriflunomide
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Genzyme, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to first clinical relapse after randomization
- Proportion of relapse free participants
- Number of of new/newly enlarged T2 lesions
- (and 11 more...)
|
165 |
All |
10 Years to 18 Years (Child, Adult) |
NCT02201108 |
EFC11759
2011-005249-12 |
TERIKIDS |
July 16, 2014 |
October 2019 |
September 2021 |
July 25, 2014 |
October 30, 2018 |
|
- Investigational Site Number 840003
Cullman, Alabama, United States - Investigational Site Number 840012
Tampa, Florida, United States - Investigational Site Number 840002
Boston, Massachusetts, United States - (and 56 more...)
|
|
| 36 |
NCT02188355 |
Recruiting |
Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- TLF
- success endpoints
- safety endpoints
- efficacy and patient oriented (composite) endpoints
|
37000 |
All |
18 Years and older (Adult, Older Adult) |
NCT02188355 |
T123E2 |
e-Ultimaster |
October 2014 |
September 2018 |
September 2019 |
July 11, 2014 |
August 3, 2017 |
|
- Fundación Favaloro
Buenos Aires, Argentina - Instituto Cardiovascular de Buenos Aires
CABA - Buenos Aires, Argentina - QANCOR Cardiovascular MC LLC
Yerevan, Armenia - (and 340 more...)
|
|
| 37 |
NCT02128932 |
Completed
Has Results |
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 2
|
- Drug: semaglutide
- Drug: insulin glargine
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in HbA1c From Baseline
- Change in Body Weight From Baseline
- Change in Fasting Plasma Glucose From Baseline
- (and 5 more...)
|
1089 |
All |
18 Years and older (Adult, Older Adult) |
NCT02128932 |
NN9535-3625
2013-004392-12
U1111-1146-0211
NL47781.018.14 |
SUSTAIN™ 4 |
August 4, 2014 |
September 3, 2015 |
September 3, 2015 |
May 1, 2014 |
March 8, 2018 |
March 8, 2018 |
- Novo Nordisk Investigational Site
Birmingham, Alabama, United States - Novo Nordisk Investigational Site
Ozark, Alabama, United States - Novo Nordisk Investigational Site
Tuscumbia, Alabama, United States - (and 228 more...)
|
|
| 38 |
NCT02021318 |
Active, not recruiting |
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa |
- Anemia in Chronic Kidney Disease in Non-dialysis Patients
|
- Drug: Roxadustat
- Drug: darbepoetin alfa
|
Interventional
|
Phase 3 |
- Astellas Pharma Europe B.V.
- FibroGen
- Astellas Pharma Inc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hemoglobin (Hb) response to treatment with Roxadustat without the use of rescue therapy
- Hb change from baseline (BL) to the average Hb, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period
- Change from BL in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol
- (and 48 more...)
|
616 |
All |
18 Years and older (Adult, Older Adult) |
NCT02021318 |
1517-CL-0610
2013-000951-42 |
Dolomites |
March 12, 2014 |
March 23, 2018 |
November 2019 |
December 27, 2013 |
January 9, 2019 |
|
- Site AT43009
Vienna, Austria - Site BY37503
Brest, Belarus - Site BY37501
Grodno, Belarus - (and 121 more...)
|
|
| 39 |
NCT01774786 |
Active, not recruiting
Has Results |
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer |
|
- Drug: 5-Fluorouracil
- Drug: Capecitabine
- Drug: Cisplatin
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Overall Survival
- Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
- Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
- (and 10 more...)
|
780 |
All |
18 Years and older (Adult, Older Adult) |
NCT01774786 |
BO25114
2012-003554-83 |
JACOB |
June 10, 2013 |
December 9, 2016 |
October 6, 2021 |
January 24, 2013 |
January 14, 2019 |
February 14, 2018 |
- Stanford Cancer Center
Stanford, California, United States - Florida Cancer Specialists - SCRI; Pharmacy
Fort Myers, Florida, United States - Cancer Institute of Florida PA
Orlando, Florida, United States - (and 193 more...)
|
|
| 40 |
NCT01239732 |
Completed
Has Results |
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer |
|
- Drug: Paclitaxel
- Drug: Bevacizumab
- Drug: Carboplatin
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With at Least One Adverse Event (AE)
- Progression-Free Survival (PFS)
- Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
- (and 5 more...)
|
1021 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01239732 |
MO22923
2010-019525-34 |
|
December 2010 |
March 2015 |
March 2015 |
November 11, 2010 |
June 10, 2016 |
June 10, 2016 |
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- (and 239 more...)
|
|
| 41 |
NCT01200758 |
Completed
Has Results |
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma |
|
- Drug: Rituximab SC
- Drug: Rituximab IV
- Drug: Cyclophosphamide
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
- Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
- Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
- (and 23 more...)
|
410 |
All |
18 Years and older (Adult, Older Adult) |
NCT01200758 |
BO22334
2010-021377-36 |
|
February 15, 2011 |
June 12, 2012 |
October 31, 2017 |
September 14, 2010 |
November 27, 2018 |
August 5, 2015 |
- Gosford Hospital; Cancer Care Services
Gosford, New South Wales, Australia - Wollongong Hospital; Cancer Services
Wollongong, New South Wales, Australia - Royal Brisbane and Women's Hospital
Herston, Queensland, Australia - (and 149 more...)
|
|
| 42 |
NCT01011738 |
Completed
Has Results |
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
- Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants
- Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants
- (and 14 more...)
|
1842 |
All |
18 Years and older (Adult, Older Adult) |
NCT01011738 |
MV22009 |
|
April 11, 2009 |
November 18, 2014 |
November 18, 2014 |
November 11, 2009 |
April 10, 2017 |
April 8, 2016 |
- Lkh-Univ. Klinikum Graz
Graz, Austria - Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie
Innsbruck, Austria - A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
Linz, Austria - (and 246 more...)
|
|
| 43 |
NCT00806819 |
Completed
Has Results |
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC |
- Carcinoma, Non-Small-Cell Lung
|
- Drug: Nintedanib (BIBF1120)
- Drug: Pemetrexed
- Drug: pemetrexed
- (and 4 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS) as Assessed by Central Independent Review
- Overall Survival (Key Secondary Endpoint)
- Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
- (and 11 more...)
|
718 |
All |
18 Years and older (Adult, Older Adult) |
NCT00806819 |
1199.14
2008-002072-10 |
|
December 2008 |
June 2011 |
December 2015 |
December 11, 2008 |
February 2, 2017 |
November 20, 2014 |
- Boehringer Ingelheim Investigational Site
Downy, California, United States - Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States - Boehringer Ingelheim Investigational Site
Fullerton, California, United States - (and 164 more...)
|
|
| 44 |
NCT00338286 |
Completed
Has Results |
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy |
- Breast Cancer
- Neoplasm Metastasis
|
- Other: Standard supportive care (packed RBC transfusion)
- Drug: epoetin alfa + packed RBC transfusion
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival
- Overall Survival
- Time to Tumor Progression
- (and 2 more...)
|
2098 |
Female |
18 Years to 99 Years (Adult, Older Adult) |
NCT00338286 |
CR005143
EPOANE3010
2005-001817-17 |
|
March 2, 2006 |
July 7, 2014 |
January 31, 2017 |
June 20, 2006 |
March 19, 2018 |
March 24, 2016 |
- Anaheim, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- (and 174 more...)
|
|
| 45 |
NCT02739568 |
Recruiting |
Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA |
- Excessive Daytime Sleepiness
- Obstructive Sleep Apnea
|
- Drug: Pitolisant (BF2.649)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Epworth sleepiness scale (ESS)
- Percentage of ESS responders
- Reduction of sleepiness and sleep episodes on the sleep diary
- (and 7 more...)
|
400 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT02739568 |
P15 13/ BF2.649 |
HAROSA3 |
April 2016 |
February 2020 |
March 2020 |
April 15, 2016 |
November 14, 2018 |
|
- Specialised Hospital for Active Treatment of pneumo-phthisiatric diseases - Burgas" EOOD, Pneumology ward
Burgas, Bulgaria - Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EOOD
Kozloduy, Bulgaria - Multiprofile Hospital for Active Treatment "Sv. Paraskeva" OOD
Pleven, Bulgaria - (and 3 more...)
|
|
| 46 |
NCT02380170 |
Recruiting |
Epidemiology and Outcomes of Gram Negative Urosepsis |
|
|
Observational
|
|
- European Association of Urology Research Foundation
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of patients with each causative pathogens and their susceptibility profile at the baseline evaluation (diagnosis of urosepsis)
- Hospital Costs (Euros) of each patients Urosepsis management
- All cause mortality
- (and 2 more...)
|
600 |
All |
18 Years and older (Adult, Older Adult) |
NCT02380170 |
2014-01 |
SERPENS |
September 2014 |
November 2017 |
November 2017 |
March 5, 2015 |
August 1, 2017 |
|
- South-Pest Teaching Hospital
Budapest, Hungary - Manzoni Hospital
Lecco, Italy - University Clinic of Surgery " St. Naum Ohridski"
Skopje, Macedonia, The Former Yugoslav Republic of - (and 4 more...)
|
|
| 47 |
NCT03755856 |
Not yet recruiting |
Long-term Outcomes for Acute Myeloid Leukemia Patients |
|
|
Observational
|
|
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- European Organisation for Research and Treatment of Cancer - EORTC
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Number of differences in SF-36 scores
|
343 |
All |
18 Years and older (Adult, Older Adult) |
NCT03755856 |
GIMEMA-EORTC 1621-QLG-LG |
1621-QLG-LG |
January 2019 |
June 2020 |
June 2020 |
November 28, 2018 |
December 17, 2018 |
|
- UZ Gasthuisberg
Leuven, Belgium - CHR Citadelle-CHU
Liège, Belgium - University of Liège
Liège, Belgium - (and 41 more...)
|
|
| 48 |
NCT03689374 |
Recruiting |
A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes |
- Diabetes Mellitus, Type 2
|
- Drug: Semaglutide
- Drug: Insulin aspart
- Drug: Insulin glargine U100
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in HbA1c
- Time to first event adjudication committee (EAC) confirmed severe hypoglycaemic episode (ADA)
- Time to first EAC confirmed severe hypoglycaemic episode (ADA) requiring hospitalisation, documented medical help, or is life threatening
- (and 35 more...)
|
2043 |
All |
18 Years and older (Adult, Older Adult) |
NCT03689374 |
NN9535-4386
U1111-1200-0164
2017-003219-20 |
SUSTAIN 11 |
October 1, 2018 |
October 2, 2020 |
November 13, 2020 |
September 28, 2018 |
January 16, 2019 |
|
- Novo Nordisk Investigational Site
Banja Luka, Bosnia and Herzegovina - Novo Nordisk Investigational Site
Sarajevo, Bosnia and Herzegovina - Novo Nordisk Investigational Site
Tuzla, Bosnia and Herzegovina - (and 188 more...)
|
|
| 49 |
NCT03504228 |
Recruiting |
Observational Study to Confirm Safety and Efficacy of the ROADSAVER Stent for the Treatment of Carotid Artery Stenosis |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- The rates of Major Adverse Events (MAE)
- Technical Success
- Procedural success
- (and 8 more...)
|
2000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03504228 |
T130E2 |
ROADSAVER |
January 23, 2018 |
January 2020 |
January 2021 |
April 20, 2018 |
September 5, 2018 |
|
- OLV Ziekenhuis
Aalst, Belgium - Imelda Ziekenhuis
Bonheiden, Belgium - AZ Sint-Blasius
Dendermonde, Belgium - (and 14 more...)
|
|
| 50 |
NCT03485911 |
Active, not recruiting |
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE |
|
- Drug: BCX7353 capsules
- Drug: Placebo oral capsule
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Part 1: The rate of investigator-confirmed HAE attacks during dosing in the entire 24-week treatment period (Day 1 to Day 168)
- Part 1: Change from baseline in Angioedema Quality of Life questionnaire at Week 24 (total score)
- Part 1: Proportion of days with angioedema symptoms through 24 weeks
- (and 6 more...)
|
96 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03485911 |
BCX7353-302 |
APeX-2 |
February 6, 2018 |
May 2019 |
June 2019 |
April 3, 2018 |
November 28, 2018 |
|
- Study center
Birmingham, Alabama, United States - Study center
Scottsdale, Arizona, United States - Study center
Little Rock, Arkansas, United States - (and 44 more...)
|
|
| 51 |
NCT03472040 |
Recruiting |
A Long Term Safety Study of BCX7353 in Hereditary Angioedema |
- Hereditary Angioedema
- HAE
- Prophylaxis
|
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The long term safety of oral BCX7353 capsules
- The rate of acute attacks of angioedema during treatment
- The durability of response to treatment
- (and 2 more...)
|
160 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03472040 |
BCX7353-204 |
APeX-S |
February 16, 2018 |
August 2019 |
August 2019 |
March 21, 2018 |
November 7, 2018 |
|
- Study Center
Adelaide, Australia - Study Center
Campbelltown, Australia - Study Center
Camperdown, Australia - (and 42 more...)
|
|
| 52 |
NCT03303313 |
Withdrawn |
A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome |
- Atypical Hemolytic Uremic Syndrome
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The effect of Cemdisiran on platelet count
- The effect of Cemdisiran on hematological response as measured by platelet count
- The effect of Cemdisiran on hematological response as measured by lactate dehydrogenase (LDH)
- (and 10 more...)
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT03303313 |
ALN-CC5-004 |
|
September 19, 2017 |
September 12, 2018 |
September 12, 2018 |
October 6, 2017 |
October 1, 2018 |
|
- Clinical Trial Site
Sarajevo, Bosnia and Herzegovina - Clinical Trial Site
Calgary, Canada - Clinical Trial Site
Tallinn, Estonia - (and 9 more...)
|
|
| 53 |
NCT03240133 |
Recruiting |
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema |
- Hereditary Angioedema (HAE)
|
- Drug: BCX7353
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Proportion of subjects with improved or stable composite visual analog scale (VAS) score
- Proportion of subject attacks with a patient global assessment of improved or stable symptoms
- Proportion of subject attacks with no symptoms or mild symptoms of an HAE attack
- (and 8 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03240133 |
BCX7353-202 |
|
July 31, 2017 |
December 2018 |
December 2018 |
August 4, 2017 |
June 11, 2018 |
|
- Study Center
Graz, Austria - Study Center
Odense, Denmark - Study Center
Grenoble, France - (and 21 more...)
|
|
| 54 |
NCT02828683 |
Completed |
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study |
- Acute ST Segment Elevation Myocardial Infarction
|
- Device: PCI in patients with ST-elevation myocardial infarction
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Target Vessel Failure (TVF)
- Target lesion failure
- Target vessel failure
- (and 6 more...)
|
500 |
All |
18 Years and older (Adult, Older Adult) |
NCT02828683 |
T120E4 |
MASTER |
July 2013 |
July 2016 |
May 2018 |
July 12, 2016 |
July 4, 2018 |
|
- Instituto Dante Pazzanese
São Paulo, Brazil - Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
Catania, Italy - Azienda Ospedaliero Universitaria Careggi
Florence, Italy - (and 10 more...)
|
|
| 55 |
NCT03023020 |
Recruiting |
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen |
- High Bleeding Risk
- Coronary Artery Disease
- PCI
|
- Drug: Aspirin
- Drug: P2Y12 inhibitor
|
Interventional
|
Not Applicable |
- ECRI bv
- Cardialysis B.V.
- European Cardiovascular Research Center
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
- Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
- Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
- (and 11 more...)
|
4300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03023020 |
ECRI-009 |
MASTER DAPT |
April 4, 2017 |
March 2019 |
May 2020 |
January 18, 2017 |
September 7, 2018 |
|
- Research Center Buenos Aires
Buenos Aires, Argentina - Research Center Perth
Perth, Australia - Research Center Sydney
Sydney, Australia - (and 100 more...)
|
|
| 56 |
NCT03021499 |
Active, not recruiting |
Aurinia Renal Response in Active Lupus With Voclosporin |
|
- Drug: Voclosporin
- Drug: Placebo Oral Capsule
|
Interventional
|
Phase 3 |
- Aurinia Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The number of subjects achieving renal response
- Time to UPCR of ≤0.5 mg/mg.
- Partial renal response
- (and 7 more...)
|
358 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03021499 |
AUR-VCS-2016-01 |
AURORA |
May 17, 2017 |
December 2019 |
March 2020 |
January 16, 2017 |
October 25, 2018 |
|
- AURORA Investigative Center
Huntsville, Alabama, United States - AURORA Investigative Center
Phoenix, Arizona, United States - AURORA Investigative Center
Phoenix, Arizona, United States - (and 184 more...)
|
|
| 57 |
NCT02870972 |
Completed |
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema |
- Hereditary Angioedema (HAE)
|
- Drug: BCX7353
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of confirmed HAE attacks
- Incidence and severity of adverse events and laboratory abnormalities
- Quality of Life, as measured by the Angioedema Quality of Life Questionnaire
- (and 2 more...)
|
75 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02870972 |
BCX7353-203 |
APeX-1 |
August 2016 |
August 2017 |
August 2017 |
August 18, 2016 |
October 26, 2017 |
|
- Adelaide, Australia
- Campbelltown, Australia
- Graz, Austria
- (and 21 more...)
|
|
| 58 |
NCT02735044 |
Completed |
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus |
|
- Drug: insulin glargine (U300)
- Drug: insulin glargine
- Drug: fast-acting insulin analogue
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in HbA1c
- Percentage of patients with HbA1c values of <7.5% without any episode of severe and/or documented (SMPG <54 mg/dL; 3.0 mmol/L) symptomatic hypoglycemia during the last 3 months of the main 6-month randomized period
- Change from baseline in Fasting Plasma Glucose (FPG)
- (and 6 more...)
|
463 |
All |
6 Years to 17 Years (Child) |
NCT02735044 |
EFC13957
2015-002084-42
U1111-1168-4546 |
EDITION JUNIOR |
April 14, 2016 |
May 31, 2018 |
December 20, 2018 |
April 12, 2016 |
January 10, 2019 |
|
- Investigational Site Number 8400008
Tucson, Arizona, United States - Investigational Site Number 8400037
Atlanta, Georgia, United States - Investigational Site Number 8400032
Indianapolis, Indiana, United States - (and 104 more...)
|
|
| 59 |
NCT02514447 |
Active, not recruiting |
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy |
|
- Drug: Trilaciclib
- Drug: Placebos
- Drug: Topotecan
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Dose Limiting Toxicity
- Treatment related adverse events (AE)
- Pharmacokinetic profile for Trilaciclib (G1T28) and Topotecan
- (and 7 more...)
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT02514447 |
G1T28-03
2016-004611-13 |
|
October 5, 2015 |
April 2019 |
August 2019 |
August 3, 2015 |
May 25, 2018 |
|
- Genesis Cancer Center
Hot Springs, Arkansas, United States - Highlands Oncology Group
Rogers, Arkansas, United States - Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States - (and 47 more...)
|
|
| 60 |
NCT00227695 |
Completed |
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma |
|
|
Interventional
|
Phase 3 |
- Swiss Group for Clinical Cancer Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event-free survival
- Progression-free survival
- Overall survival
- Adverse reactions during and after maintenance treatment
|
270 |
All |
18 Years and older (Adult, Older Adult) |
NCT00227695 |
SAKK 35/03
SWS-SAKK-35/03
EU-20520
CDR0000443594 |
|
June 8, 2004 |
May 3, 2013 |
December 19, 2017 |
September 28, 2005 |
January 17, 2018 |
|
- Clinical Center - Institute of Hematology
Sao Paulo, Brazil - Istituto Europeo di Oncologia IEO
Milano, Italy - Clinical Center Skopje
Skopje, Macedonia, The Former Yugoslav Republic of - (and 23 more...)
|
|
| 61 |
NCT00879541 |
Completed |
Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A |
|
- Biological: Biostate® [SP]
- Biological: Biostate® [RP]
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Haemostatic efficacy
- Number of treatments/units required to resolve any bleeding event
- FVIII concentrate usage (number of infusions, IU/kg per event, per month, and per year)
- (and 4 more...)
|
81 |
Male |
12 Years and older (Child, Adult, Older Adult) |
NCT00879541 |
CSLCT-BIO-07-47
1472 |
|
February 2009 |
October 2010 |
October 2010 |
April 10, 2009 |
February 11, 2011 |
|
- Study Site
Plovdiv, Bulgaria - Study Site
Sofia, Bulgaria - Study Site
Varna, Bulgaria - (and 11 more...)
|
|
| 62 |
NCT02256917 |
Completed |
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A |
|
- Biological: Human cl rhFVIII
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Annualized total bleeding rate of individually tailored prophylaxis
- Annualized spontaneous bleeding rate of individually tailored prophylaxis
- Annualized total bleeding rate in patients with 2x/week (or less) prophylaxis
- (and 3 more...)
|
58 |
Male |
18 Years and older (Adult, Older Adult) |
NCT02256917 |
GENA-21B |
|
May 2015 |
September 2018 |
September 2018 |
October 6, 2014 |
November 21, 2018 |
|
- Octapharma Research Site
Sacramento, California, United States - Octapharma Research Site
Aurora, Colorado, United States - Octapharma Research Site
Washington, District of Columbia, United States - (and 27 more...)
|
|
| 63 |
NCT02247739 |
Completed
Has Results |
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor |
|
- Biological: Recombinant human C1 inhibitor
- Other: Placebo
|
Interventional
|
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of HAE Attacks
- Number of Participants With Adverse Events
- Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks
|
32 |
All |
13 Years and older (Child, Adult, Older Adult) |
NCT02247739 |
C1 3201 |
|
December 2014 |
May 2016 |
September 2016 |
September 25, 2014 |
December 8, 2017 |
December 8, 2017 |
- University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States - University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States - Washington University Division of Allergy and Immunology
Saint Louis, Missouri, United States - (and 7 more...)
|
|
| 64 |
NCT00846911 |
Completed |
AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs |
|
- Drug: Moxifloxacin (Avelox, BAY12-8039)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Time until improvement of acute exacerbation
- Time until cure of acute exacerbation
- Severity of AECB according to Antonisen criteria
- (and 2 more...)
|
2672 |
All |
35 Years and older (Adult, Older Adult) |
NCT00846911 |
14689
AX0701
13598
13855
13856
13857
14008
14007
14009 |
|
April 2008 |
April 2010 |
April 2010 |
February 19, 2009 |
July 9, 2012 |
|
- Many Locations, Albania
- Many Locations, Bosnia and Herzegovina
- Many Locations, Kazakhstan
- (and 5 more...)
|
|
| 65 |
NCT02195479 |
Active, not recruiting
Has Results |
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma |
|
- Drug: Velcade
- Drug: Melphalan
- Drug: Prednisone
- (and 2 more...)
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Response Rate (ORR)
- Percentage of Participants With Very Good Partial Response (VGPR) or Better
- (and 13 more...)
|
706 |
All |
18 Years and older (Adult, Older Adult) |
NCT02195479 |
CR104761
54767414MMY3007
2014-002272-88 |
|
December 9, 2014 |
November 21, 2017 |
October 20, 2021 |
July 21, 2014 |
December 17, 2018 |
December 17, 2018 |
- California City, California, United States
- Corona, California, United States
- Fountain Valley, California, United States
- (and 162 more...)
|
|
| 66 |
NCT00777296 |
Completed |
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) |
|
- Drug: Arikayce™
- Drug: Placebo
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability of nebulized Arikace™. Safety will be evaluated by changes in FEV1, SaO2, chemistry and hematology lab tests, vital signs, and clinical exam, assess treatment-emergent AEs.
- To assess pharmacokinetics (PK) of Arikace™ in serum
- To assess pharmacokinetics (PK) of Arikace™ in urine
- (and 5 more...)
|
|
All |
6 Years and older (Child, Adult, Older Adult) |
NCT00777296 |
TR02-105 |
|
February 2007 |
February 2008 |
February 2010 |
October 22, 2008 |
November 18, 2016 |
|
- Leuven, Belgium
- Budapest, Hungary
- Kaposvar, Hungary
- (and 8 more...)
|
|
| 67 |
NCT02112981 |
Active, not recruiting |
BioMime Vs. Xience Randomised Control Clinical Study |
|
- Device: Sirolimus Eluting Coronary Stent
- Device: Everolimus-eluting Coronary stent
|
Interventional
|
Not Applicable |
- Meril Life Sciences Pvt. Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess in-stent Late Lumen Loss
- Frequency of Binary restenosis by Angiography
- Minimum Lumen Diameter by Angiography
- (and 2 more...)
|
256 |
All |
18 Years and older (Adult, Older Adult) |
NCT02112981 |
BioM/RCT/12/03
2013-005353-67 |
meriT-V |
November 5, 2014 |
September 6, 2017 |
December 1, 2019 |
April 14, 2014 |
August 17, 2018 |
|
- Imelda Ziekenhuis Cardiology
Bonheiden, Western Europe, Belgium - Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil - Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
São Paulo, Brazil - (and 12 more...)
|
|
| 68 |
NCT02099617 |
Active, not recruiting |
Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization. |
- Stable Angina
- Silent Myocardial Ischemia
- Acute Coronary Syndrome
|
- Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
- Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
- Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
|
Interventional
|
Phase 4 |
- Ceric Sàrl
- Boston Scientific; Pr Olivier Varenne
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
|
1200 |
All |
75 Years and older (Older Adult) |
NCT02099617 |
10-389 |
SENIOR |
May 2014 |
May 2017 |
June 2018 |
March 31, 2014 |
May 2, 2017 |
|
- CHU St Pierre
Brussels, Belgium - Centre Hospitalier de Jolimont
La Louvière, Belgium - UZ Leuven
Leuven, Belgium - (and 41 more...)
|
|
| 69 |
NCT02040441 |
Completed |
Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria |
- Diabetic Nephropathy
- Diabetic Retinopathy
|
- Drug: Spironolactone
- Drug: Placebo
- Drug: Standard care
|
Interventional
|
Phase 2
Phase 3 |
- Peter Rossing
- Mosaiques Diagnostics GmbH
- University Medical Center Groningen
- (and 16 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Albuminuria
- Cardiovascular disease and mortality
- Retinopathy
- (and 5 more...)
|
1777 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02040441 |
2012-000452-34 |
PRIORITY |
March 2014 |
November 2018 |
November 2018 |
January 20, 2014 |
December 21, 2018 |
|
- Universitair Ziekenhuis
Gent, Belgium - Institut Klinické a Experimentální Mediciny
Prague, Czechia - Universita Karlova v Praze
Prague, Czechia - (and 12 more...)
|
|
| 70 |
NCT01973244 |
Completed |
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency |
- Growth Hormone Disorder
- Growth Hormone Deficiency in Children
|
- Drug: somapacitan
- Drug: somatropin
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs)
- The area under the insulin-like growth factor I (IGF-I) concentration-time curve
|
32 |
All |
6 Years to 13 Years (Child) |
NCT01973244 |
NN8640-4042
2013-000013-20
U1111-1138-2206
REec-2014-0688
JapicCTI-142663 |
|
December 16, 2013 |
November 4, 2014 |
November 4, 2014 |
October 31, 2013 |
May 25, 2018 |
|
- Novo Nordisk Investigational Site
Graz, Austria - Novo Nordisk Investigational Site
Linz, Austria - Novo Nordisk Investigational Site
Wien, Austria - (and 19 more...)
|
|
| 71 |
NCT01946620 |
Completed |
A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD |
- Chronic Obstructive Pulmonary Disease
|
- Drug: Flutiform
- Drug: Formoterol
|
Interventional
|
Phase 3 |
- Mundipharma Research Limited
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Annual rate of moderate and severe COPD exacerbations
- Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.
|
1767 |
All |
40 Years and older (Adult, Older Adult) |
NCT01946620 |
FLT3509
2012-004162-17 |
|
October 2013 |
April 2016 |
May 2016 |
September 19, 2013 |
October 24, 2018 |
|
- Sofia, Bulgaria
- Hamburg, Germany
- Budapest, Hungary
- (and 12 more...)
|
|
| 72 |
NCT01911234 |
Completed |
Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in DAS28-CRP between Month 6 and baseline.
- Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline
- Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
- Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory evaluations, and the recording of adverse events (AEs)
|
143 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01911234 |
TNF-K-006
2013-001999-38 |
|
September 2013 |
September 2014 |
September 2014 |
July 30, 2013 |
January 14, 2015 |
|
- Cliniques Universitaires Saint Luc
Brussels, Belgium - "Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
Tbilisi, Georgia - "Medi Club Georgia" LLC
Tbilisi, Georgia - (and 28 more...)
|
|
| 73 |
NCT01905943 |
Completed
Has Results |
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia |
- Chronic Lymphocytic Leukemia
|
- Drug: Bendamustine
- Drug: Chlorambucil
- Drug: Cyclophosphamide
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events (AEs)
- Number of Participants With Adverse Events of Special Interest (AESIs)
- Number of Participants With Adverse Events of Particular Interest (AEPIs)
- (and 9 more...)
|
979 |
All |
18 Years and older (Adult, Older Adult) |
NCT01905943 |
MO28543
2013-000087-29 |
|
November 4, 2013 |
December 29, 2016 |
October 8, 2018 |
July 23, 2013 |
December 11, 2018 |
October 29, 2018 |
- Hospital Iturraspe
Santa Fé, Argentina - Hospital Erasme; Neurologie
Bruxelles, Belgium - Cliniques Universitaires St-Luc
Bruxelles, Belgium - (and 178 more...)
|
|
| 74 |
NCT01835431 |
Completed
Has Results |
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus |
- Diabetes
- Diabetes Mellitus, Type 1
|
- Drug: insulin degludec/insulin aspart
- Drug: insulin aspart
- Drug: insulin detemir
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
- Change From Baseline in Fasting Plasma Glucose
- Incidence of Treatment Emergent Adverse Events (TEAEs)
- (and 4 more...)
|
362 |
All |
1 Year to 17 Years (Child) |
NCT01835431 |
NN5401-3816
2012-003566-41
U1111-1133-0958
PIP no. be confirmed |
|
October 17, 2013 |
November 7, 2014 |
November 7, 2014 |
April 19, 2013 |
September 10, 2018 |
November 17, 2015 |
- Novo Nordisk Investigational Site
Phoenix, Arizona, United States - Novo Nordisk Investigational Site
Tucson, Arizona, United States - Novo Nordisk Investigational Site
Sacramento, California, United States - (and 70 more...)
|
|
| 75 |
NCT01675427 |
Completed
Has Results |
A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C |
|
- Other: Interleukin 28B testing
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive
- Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced
- Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive
- (and 91 more...)
|
4766 |
All |
18 Years and older (Adult, Older Adult) |
NCT01675427 |
MV25600 |
|
August 2011 |
October 2013 |
October 2013 |
August 30, 2012 |
August 26, 2015 |
June 8, 2015 |
- Alexandria, Virginia, United States
- Buenos Aires, Argentina
- Mar del Plata, Argentina
- (and 207 more...)
|
|
| 76 |
NCT01541215 |
Completed
Has Results |
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 2
|
- Drug: liraglutide
- Drug: placebo
- Drug: metformin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in HbA1c (Glycosylated Haemoglobin)
- Change From Baseline in Fasting Plasma Glucose (FPG)
- Number of Subjects Having HbA1c Below 7.0%
- (and 43 more...)
|
135 |
All |
10 Years to 17 Years (Child) |
NCT01541215 |
NN2211-3659
2011-002605-29
P/288/2010
U1111-1121-8743
CTRI/2013/10/004082 |
Ellipse™ |
November 13, 2012 |
November 15, 2017 |
May 23, 2018 |
February 29, 2012 |
December 11, 2018 |
December 11, 2018 |
- Novo Nordisk Investigational Site
Birmingham, Alabama, United States - Novo Nordisk Investigational Site
Phoenix, Arizona, United States - Novo Nordisk Investigational Site
Tucson, Arizona, United States - (and 182 more...)
|
|
| 77 |
NCT01513473 |
Completed
Has Results |
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus |
- Diabetes
- Diabetes Mellitus, Type 1
|
- Drug: insulin degludec
- Drug: insulin detemir
- Drug: insulin aspart
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
- Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
- Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
- (and 7 more...)
|
350 |
All |
1 Year to 17 Years (Child) |
NCT01513473 |
NN1250-3561
2011-003148-39
P/44/2010
U1111-1122-4758 |
BEGIN™ |
January 2012 |
July 2013 |
July 2013 |
January 20, 2012 |
March 3, 2017 |
January 12, 2016 |
- Novo Nordisk Investigational Site
Little Rock, Arkansas, United States - Novo Nordisk Investigational Site
Orange, California, United States - Novo Nordisk Investigational Site
San Diego, California, United States - (and 78 more...)
|
|
| 78 |
NCT01486940 |
Completed |
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 1
|
- Drug: insulin detemir
- Drug: insulin aspart
- Drug: insulin NPH
- Drug: human soluble insulin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HbA1c (glycosylated haemoglobin)
- Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
- 8-point blood glucose profiles
- (and 2 more...)
|
598 |
All |
18 Years and older (Adult, Older Adult) |
NCT01486940 |
NN304-1374 |
|
March 2002 |
October 2002 |
October 2002 |
December 7, 2011 |
January 27, 2017 |
|
- Novo Nordisk Investigational Site
Junin, Argentina - Novo Nordisk Investigational Site
Moron, Argentina - Novo Nordisk Investigational Site
Varazdin, Croatia - (and 72 more...)
|
|
| 79 |
NCT01447446 |
Completed
Has Results |
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C |
|
- Drug: Peg-IFN Alfa-2a
- Drug: Peg-IFN Alfa-2b
- Drug: Ribavirin
- (and 2 more...)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
- Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
- Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
- (and 11 more...)
|
4442 |
All |
18 Years and older (Adult, Older Adult) |
NCT01447446 |
MV25599 |
|
September 2011 |
July 2015 |
July 2015 |
October 6, 2011 |
March 30, 2017 |
March 30, 2017 |
- Antwerpen, Belgium
- Antwerpen, Belgium
- Bouge, Belgium
- (and 269 more...)
|
|
| 80 |
NCT01397864 |
Recruiting |
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks |
|
|
Observational
|
|
- Pharming Technologies B.V.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INHof acute angioedema attacks
- To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)
|
300 |
All |
Child, Adult, Older Adult |
NCT01397864 |
C1 1412 |
|
July 2011 |
December 2019 |
June 2020 |
July 20, 2011 |
April 4, 2018 |
|
- UMHAT Alexandrovska EAD
Sofia, Bulgaria - Faculty Hospital by St. Anna Brno
Brno, Czechia - Hospital A Michallon, CHU Grenoble
La Tronche, France - (and 10 more...)
|
|
| 81 |
NCT01395810 |
Completed
Has Results |
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 |
- Congenital Bleeding Disorder
- Haemophilia B
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)
- Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)
- Number of Bleeding Episodes During Routine Prophylaxis
- (and 3 more...)
|
71 |
Male |
13 Years to 70 Years (Child, Adult, Older Adult) |
NCT01395810 |
NN7999-3775
2010-023072-17
U1111-1121-5408
JapicCTI-121812 |
paradigm™ 4 |
April 15, 2012 |
March 30, 2014 |
March 30, 2014 |
July 18, 2011 |
May 9, 2018 |
May 9, 2018 |
- Novo Nordisk Investigational Site
Los Angeles, California, United States - Novo Nordisk Investigational Site
San Francisco, California, United States - Novo Nordisk Investigational Site
Washington, District of Columbia, United States - (and 46 more...)
|
|
| 82 |
NCT01386528 |
Completed
Has Results |
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B |
- Congenital Bleeding Disorder
- Haemophilia B
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
- Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
- Transfusion Requirements (Fulfilling Transfusion Criteria)
- (and 4 more...)
|
13 |
Male |
13 Years to 70 Years (Child, Adult, Older Adult) |
NCT01386528 |
NN7999-3773
2010-023070-40
U1111-1121-4554 |
paradigm™ 3 |
June 7, 2012 |
December 1, 2013 |
December 1, 2013 |
July 1, 2011 |
August 23, 2017 |
July 24, 2017 |
- Novo Nordisk Investigational Site
Los Angeles, California, United States - Novo Nordisk Investigational Site
San Francisco, California, United States - Novo Nordisk Investigational Site
Washington, D.C., District of Columbia, United States - (and 38 more...)
|
|
| 83 |
NCT01359969 |
Completed |
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients |
|
|
Interventional
|
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with Adverse Events
- Number of patients with positive neutralizing C1INH and rhC1INH specific antibody tests
- Number of patients with confirmed host related impurities antibodies (Anti-HRI) after exposure to rhC1INH
- (and 6 more...)
|
20 |
All |
2 Years to 13 Years (Child) |
NCT01359969 |
C1 1209
2011-000987-92 |
|
January 17, 2012 |
July 17, 2017 |
July 17, 2017 |
May 25, 2011 |
July 18, 2018 |
|
- Portland Clinical Research/AAIM Care, LLC
Portland, Oregon, United States - UIA FN Plzen ( Institute of Immunology and Allergology), Faculty Hospital Plzen
Plzen, Alej Svobody 80, Czechia - University Hospital Motol, Institute of Immunology
Prague, V Úvalu 84, Czechia - (and 13 more...)
|
|
| 84 |
NCT01344889 |
Completed |
An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C) |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
- Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment)
- Correlation of on-treatment factors and dose reduction/treatment discontinuation
- (and 3 more...)
|
4459 |
All |
18 Years and older (Adult, Older Adult) |
NCT01344889 |
MV22255 |
|
October 2009 |
June 2013 |
June 2013 |
April 29, 2011 |
November 2, 2016 |
|
- Elbasan, Albania
- Tirana, Albania
- Algiers, Algeria
- (and 258 more...)
|
|
| 85 |
NCT01342822 |
Unknown † |
Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization |
- Ischemic Heart Disease
- Coronary Artery Stenosis
|
- Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)
|
Observational
|
|
- European Cardiovascular Research Center
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Target Vessel failure (TVF)
- Clinical endpoints
|
2980 |
All |
18 Years and older (Adult, Older Adult) |
NCT01342822 |
BSI-01 |
PLATINUM+ |
October 2010 |
March 2014 |
March 2014 |
April 27, 2011 |
March 13, 2012 |
|
- Clinique de l'Europe
Amiens, France - Polyclinique de Bois Bernard
Bois-bernard, France - Clinique Saint Augustin
Bordeaux, France - (and 47 more...)
|
|
| 86 |
NCT01333111 |
Completed
Has Results |
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients |
- Congenital Bleeding Disorder
- Haemophilia B
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
- Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
- Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
- (and 5 more...)
|
74 |
Male |
13 Years to 70 Years (Child, Adult, Older Adult) |
NCT01333111 |
NN7999-3747
2010-023069-24
U1111-1119-6415
JapicCTI-111644 |
paradigm™ 2 |
April 27, 2011 |
March 31, 2013 |
March 31, 2013 |
April 11, 2011 |
July 28, 2017 |
July 28, 2017 |
- Novo Nordisk Investigational Site
Los Angeles, California, United States - Novo Nordisk Investigational Site
Jacksonville, Florida, United States - Novo Nordisk Investigational Site
Augusta, Georgia, United States - (and 40 more...)
|
|
| 87 |
NCT01307397 |
Completed
Has Results |
A Study of Vemurafenib in Participants With Metastatic Melanoma |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
- Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation
- Percentage of Participants With AEs of Special Interest
- (and 13 more...)
|
3219 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01307397 |
MO25515
2010-023526-21 |
|
March 1, 2011 |
February 24, 2016 |
February 24, 2016 |
March 2, 2011 |
December 18, 2017 |
December 18, 2017 |
- University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania - Hospital Britanico; Oncologia
Buenos Aires, Argentina - Fundación CIDEA
Buenos Aires, Argentina - (and 277 more...)
|
|
| 88 |
NCT01241396 |
Completed |
A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure |
|
|
Observational
|
|
- Janssen Pharmaceutica N.V., Belgium
|
Industry |
- Observational Model: Case-Only
|
- Description of current treatment regimens for MMY.
- Utilisation of current treatment regimens for MMY
- Quality of life and health economic parameters associated with MMY treatment regimens
- (and 2 more...)
|
2396 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01241396 |
CR017410 |
|
October 2010 |
November 2014 |
November 2014 |
November 16, 2010 |
June 20, 2016 |
|
- Alger, Algeria
- Constantine, Algeria
- Oran, Algeria
- (and 158 more...)
|
|
| 89 |
NCT01188564 |
Completed
Has Results |
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks |
|
- Drug: rhC1INH
- Drug: Placebo (Saline)
|
Interventional
|
Phase 3 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to Beginning of Relief of Symptoms
- Time to Minimal Symptoms
|
75 |
All |
13 Years and older (Child, Adult, Older Adult) |
NCT01188564 |
C1 1310 |
|
January 2011 |
December 2012 |
March 2013 |
August 25, 2010 |
August 7, 2015 |
August 7, 2015 |
- Allergy, Asthma & Immunology, Assoc, Ltd.
Scottsdale, Arizona, United States - Allergy and Asthma Institute of the Valley
Granada Hills, California, United States - UCLA Department of Medicine Division of Clinical Immunology, David Geffen School of Medicine
Los Angeles, California, United States - (and 24 more...)
|
|
| 90 |
NCT01182493 |
Completed
Has Results |
OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy |
- Diabetes Mellitus, Type 2
|
- Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Between Group Difference in HbA1c When Comparing CSII to MDI
- Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)
- Safety - Severe Hypoglycemia Incidence
- (and 4 more...)
|
331 |
All |
30 Years to 75 Years (Adult, Older Adult) |
NCT01182493 |
EUR05 / CEP234 |
OpT2mise |
December 2010 |
February 2014 |
August 2014 |
August 16, 2010 |
March 12, 2018 |
March 15, 2016 |
- Atlanta Diabetes Associates
Atlanta, Georgia, United States - Albany Medical College
Albany, New York, United States - SUNY Upstate Medical University
Syracuse, New York, United States - (and 33 more...)
|
|
| 91 |
NCT01165684 |
Completed
Has Results |
Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen |
- Diabetes
- Diabetes Mellitus, Type 2
|
- Drug: insulin aspart
- Drug: insulin detemir
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
- (and 12 more...)
|
401 |
All |
18 Years and older (Adult, Older Adult) |
NCT01165684 |
ANA-3786
2010-018974-19
U1111-1116-0908 |
Full STEP™ |
October 2010 |
April 2012 |
April 2012 |
July 20, 2010 |
February 17, 2017 |
June 11, 2013 |
- Novo Nordisk Investigational Site
Birmingham, Alabama, United States - Novo Nordisk Investigational Site
Mesa, Arizona, United States - Novo Nordisk Investigational Site
Scottsdale, Arizona, United States - (and 64 more...)
|
|
| 92 |
NCT01149044 |
Completed |
A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI |
- Acute Coronary Syndrome
- ST Elevation Myocardial Infarction
- Percutaneous Coronary Intervention
|
- Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
|
Interventional
|
Not Applicable |
- Population Health Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
- Stroke
- Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure
- (and 2 more...)
|
10732 |
All |
19 Years and older (Adult, Older Adult) |
NCT01149044 |
TOTAL Trial |
TOTAL |
August 2010 |
March 2015 |
October 2015 |
June 23, 2010 |
October 20, 2015 |
|
- Central Cardiology medical Clinic
Bakersfield, California, United States - Emory University Hospital Midtown
Atlanta, Georgia, United States - University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States - (and 84 more...)
|
|
| 93 |
NCT01138501 |
Completed
Has Results |
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A |
- Congenital Bleeding Disorder
- Haemophilia A
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
- Frequency of Adverse Events (AEs)
|
65 |
Male |
up to 11 Years (Child) |
NCT01138501 |
NN7008-3545
U1111-1113-7182
2009-016383-36 |
guardian™ 3 |
June 2010 |
November 2011 |
November 2011 |
June 7, 2010 |
March 17, 2017 |
June 11, 2014 |
- Novo Nordisk Investigational Site
Phoenix, Arizona, United States - Novo Nordisk Investigational Site
Orange, California, United States - Novo Nordisk Investigational Site
Torrance, California, United States - (and 35 more...)
|
|
| 94 |
NCT01120184 |
Completed
Has Results |
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) |
|
- Drug: docetaxel
- Drug: paclitaxel
- Drug: pertuzumab
- (and 3 more...)
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Genentech, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
- Progression-Free Survival (PFS) According to IRF Assessment
- Percentage of Participants Who Died Prior to Clinical Cutoff
- (and 36 more...)
|
1095 |
All |
18 Years and older (Adult, Older Adult) |
NCT01120184 |
BO22589
2009-017905-13 |
|
July 31, 2010 |
September 30, 2014 |
September 16, 2016 |
May 10, 2010 |
November 7, 2017 |
February 23, 2017 |
- Arizona Oncology
Tucson, Arizona, United States - Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center
Little Rock, Arkansas, United States - Little Rock Hematology Oncology Associates, PA
Little Rock, Arkansas, United States - (and 296 more...)
|
|
| 95 |
NCT01085487 |
Completed |
MiCo - Mirena or Conventional Medical Treatment for Menorrhagia |
|
- Drug: Levonorgestrel (Mirena, BAY86-5028)
- Drug: Hormonal treatment
- Drug: Antifibrinolytic treatment
|
Observational
|
|
|
Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Cumulative continuation rate at 12 months stratified by history of previous treatment(s) for menorrhagia
- Bleeding pattern
- Patient satisfaction at end of documentation
- (and 2 more...)
|
1211 |
Female |
18 Years to 45 Years (Adult) |
NCT01085487 |
14536
MA0901
MA0701-14697 |
|
April 2009 |
|
June 2011 |
March 12, 2010 |
April 10, 2012 |
|
- Many Locations, Albania
- Many Locations, Bosnia and Herzegovina
- Many Locations, Colombia
- (and 11 more...)
|
|
| 96 |
NCT01076764 |
Completed |
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy |
|
- Drug: Otamixaban
- Drug: Placebo (for Otamixaban)
- Drug: UFH
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
- Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)
- Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke
- (and 3 more...)
|
13220 |
All |
18 Years and older (Adult, Older Adult) |
NCT01076764 |
EFC6204
2009-016568-36 |
TAO |
April 2010 |
May 2013 |
May 2013 |
February 26, 2010 |
May 4, 2016 |
|
- Investigational Site Number 840015
Huntsville, Alabama, United States - Investigational Site Number 840569
Phoenix, Arizona, United States - Investigational Site Number 840703
Phoenix, Arizona, United States - (and 604 more...)
|
|
| 97 |
NCT01074268 |
Completed
Has Results |
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 1
|
- Drug: insulin degludec
- Drug: insulin detemir
- Drug: insulin aspart
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
- Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
- (and 8 more...)
|
456 |
All |
18 Years and older (Adult, Older Adult) |
NCT01074268 |
NN1250-3585
2009-011672-29
U1111-1111-7249
JapicCTI-101067
2009-015721-36
U1111-1114-9479
JapicCTI-22-0677 |
BEGIN™ |
February 2010 |
December 2010 |
December 2010 |
February 24, 2010 |
March 6, 2017 |
November 16, 2015 |
- Novo Nordisk Investigational Site
Caba, Argentina - Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, Argentina - Novo Nordisk Investigational Site
Mar del Plata, Argentina - (and 66 more...)
|
|
| 98 |
NCT01070550 |
Completed
Has Results |
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a) |
|
- Drug: Peginterferon alfa-2a (Pegasys®)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population
- Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population
- Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population
- (and 19 more...)
|
4680 |
All |
18 Years and older (Adult, Older Adult) |
NCT01070550 |
MV21012 |
|
June 2007 |
July 2011 |
July 2011 |
February 18, 2010 |
June 15, 2016 |
June 15, 2016 |
- Gratwein, Austria
- Graz, Austria
- Innsbruck, Austria
- (and 263 more...)
|
|
| 99 |
NCT01007435 |
Completed
Has Results |
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis |
|
- Drug: Tocilizumab
- Drug: Placebo to tocilizumab
- Drug: Methotrexate
- Drug: Placebo to methotrexate
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
- Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52
- Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
- (and 6 more...)
|
1162 |
All |
18 Years and older (Adult, Older Adult) |
NCT01007435 |
WA19926
2009-012759-12 |
|
October 31, 2009 |
May 31, 2012 |
January 28, 2014 |
November 4, 2009 |
July 26, 2017 |
July 12, 2013 |
- Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States - Rheumatology Associates of North Alabama
Huntsville, Alabama, United States - Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama, United States - (and 233 more...)
|
|
| 100 |
NCT01006291 |
Completed
Has Results |
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes |
- Diabetes
- Diabetes Mellitus, Type 2
|
- Drug: insulin degludec
- Drug: insulin glargine
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Glycosylated Haemoglobin (HbA1c)
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
- Rate of Confirmed Hypoglycaemic Episodes
- Rate of Nocturnal Confirmed Hypoglycaemic Episodes
|
687 |
All |
18 Years and older (Adult, Older Adult) |
NCT01006291 |
NN1250-3668
U1111-1111-7084
2008-005771-10 |
BEGIN™ |
November 2009 |
September 2010 |
September 2010 |
November 2, 2009 |
February 9, 2017 |
November 13, 2015 |
- Novo Nordisk Investigational Site
Buenos Aires, Argentina - Novo Nordisk Investigational Site
Buenos Aires, Argentina - Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, Argentina - (and 69 more...)
|
|
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