| 1 |
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
|
| 2 |
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, Senior) |
NCT01730456 |
ML28133 |
|
October 2012 |
May 2015 |
May 2015 |
November 21, 2012 |
November 2, 2016 |
|
- Skopje, Macedonia, The Former Yugoslav Republic of
|
| 3 |
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, Senior) |
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
|
| 4 |
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, Senior |
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
|
| 5 |
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, Senior |
NCT00842894 |
NN304-3716 |
|
May 2009 |
October 2010 |
October 2010 |
February 12, 2009 |
August 15, 2014 |
|
- Skopje, Macedonia, The Former Yugoslav Republic of
|
| 6 |
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, Senior |
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
|
| 7 |
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) |
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
|
| 8 |
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, Senior) |
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
|
| 9 |
NCT02663323 |
Recruiting |
Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System |
|
- Device: MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
|
Interventional |
Phase 2
Phase 3 |
- 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, Senior) |
NCT02663323 |
MER/EX |
MeRes-1 Extend |
February 2016 |
December 2019 |
|
January 26, 2016 |
December 1, 2016 |
|
- 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
|
| 10 |
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, Senior) |
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...)
|
| 11 |
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, Senior) |
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...)
|
| 12 |
NCT02111564 |
Recruiting |
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 6 more...)
|
12000 |
All |
40 Years and older (Adult, Senior) |
NCT02111564 |
CR103834
2014-000305-13
RIVAROXDVT3002 |
MARINER |
June 2, 2014 |
May 25, 2018 |
May 25, 2018 |
April 11, 2014 |
April 9, 2018 |
|
- Achieve Clinical Research, LLC
Birmingham, Alabama, United States - The Heart Center, PC - Huntsville Hospital
Huntsville, Alabama, United States - Mobile Heart Specialists, PC
Mobile, Alabama, United States - (and 1501 more...)
|
| 13 |
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...)
|
| 14 |
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, Senior) |
NCT01313676 |
113782 |
|
January 25, 2011 |
July 15, 2015 |
July 15, 2015 |
March 14, 2011 |
January 24, 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...)
|
| 15 |
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, Senior) |
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...)
|
| 16 |
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, Senior) |
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...)
|
| 17 |
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, Senior) |
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...)
|
| 18 |
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 7 more...)
|
450 |
All |
18 Years and older (Adult, Senior) |
NCT03337724 |
CO40016
2017-001548-36 |
IPATunity130 |
January 6, 2018 |
March 13, 2021 |
March 13, 2021 |
November 9, 2017 |
March 29, 2018 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States - Kaiser Permanente - Oakland
Oakland, California, United States - Emad Ibrahim, Md, Inc
Redlands, California, United States - (and 163 more...)
|
| 19 |
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 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 28, 2013 |
March 9, 2017 |
April 19, 2017 |
October 16, 2012 |
May 17, 2017 |
|
- Teva Investigational Site 10329
Cullman, Alabama, United States - Teva Investigational Site 10310
Fresno, California, United States - Teva Investigational Site 10307
Aurora, Colorado, United States - (and 212 more...)
|
| 20 |
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, Senior) |
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...)
|
| 21 |
NCT01196091 |
Completed |
A Study of LY2127399 in Patients With Systemic Lupus Erythematosus |
- Systemic Lupus Erythematosus
- Connective Tissue Disease
- Autoimmune Disease
|
- Drug: LY2127399
- Drug: Placebo every 2 weeks
- Drug: Placebo every 4 weeks
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of patients achieving an SLE Responder Index response at week 52
- Proportion of patients 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, Senior) |
NCT01196091 |
13656
H9B-MC -BCDS |
|
December 2010 |
July 2014 |
June 2015 |
September 8, 2010 |
February 2, 2016 |
|
- 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...)
|
| 22 |
NCT01047319 |
Terminated |
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
|
- To assess the long-term safety and tolerability of Laquinimod 0.6 mg, by analyzing rates and severity of adverse events and serious adverse events changes in laboratory parameters and physical examination findings.
- To assess the long-term effects of laquinimod 0.6 mg on the disease course by analyzing relapse rate, progression of physical disability (EDSS and MSFC scores), fatigue and low-contrast visual acuity.
|
634 |
All |
Child, Adult, Senior |
NCT01047319 |
MS-LAQ-302E
2009-015815-42 |
|
April 30, 2010 |
May 9, 2017 |
May 9, 2017 |
January 12, 2010 |
September 14, 2017 |
|
- 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 134 more...)
|
| 23 |
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...)
|
| 24 |
NCT00567190 |
Active, not recruiting
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, Senior) |
NCT00567190 |
TOC4129g
WO20698
2007-002997-72 |
CLEOPATRA |
February 12, 2008 |
May 13, 2011 |
October 23, 2018 |
December 4, 2007 |
March 16, 2018 |
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...)
|
| 25 |
NCT02978716 |
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...)
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT02978716 |
G1T28-04
2016-004466-26 |
|
January 2017 |
December 2018 |
December 2019 |
December 1, 2016 |
December 11, 2017 |
|
- 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...)
|
| 26 |
NCT02518620 |
Active, not recruiting |
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, Senior) |
NCT02518620 |
ALX0061-C203
2014-003034-42 |
|
July 2015 |
September 2018 |
|
August 10, 2015 |
September 11, 2017 |
|
- Investigator Site
Brussels, Belgium - Investigator Site 2
Brussels, Belgium - Investigator Site
Ghent, Belgium - (and 54 more...)
|
| 27 |
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, Senior) |
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...)
|
| 28 |
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, Senior) |
NCT02287922 |
ALX0061-C202
2014-003012-36 |
|
February 2015 |
July 2016 |
July 2016 |
November 11, 2014 |
September 6, 2017 |
|
- Investigator Site
Birmingham, Alabama, United States - Investigator Site
Hemet, California, United States - Investigator Site
La Palma, California, United States - (and 80 more...)
|
| 29 |
NCT02201108 |
Active, not recruiting |
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis |
|
- Drug: Teriflunomide HMR1726
- Drug: Placebo
|
Interventional |
Phase 3 |
- Genzyme, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to first clinical relapse after randomization
- Proportion of relapse free patients
- Number of of new/newly enlarged T2 lesions
- (and 9 more...)
|
166 |
All |
10 Years to 17 Years (Child) |
NCT02201108 |
EFC11759
PIP - 2011-005249-12
U1111-1124-0983 |
TERIKIDS |
July 16, 2014 |
December 2019 |
September 29, 2021 |
July 25, 2014 |
March 9, 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...)
|
| 30 |
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, Senior) |
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...)
|
| 31 |
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, Senior) |
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...)
|
| 32 |
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, Senior) |
NCT02021318 |
1517-CL-0610
2013-000951-42 |
Dolomites |
March 12, 2014 |
March 23, 2018 |
October 2019 |
December 27, 2013 |
April 17, 2018 |
|
- Site AT43009
Vienna, Austria - Site BY37503
Brest, Belarus - Site BY37501
Grodno, Belarus - (and 111 more...)
|
| 33 |
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, Senior) |
NCT01774786 |
BO25114
2012-003554-83 |
|
June 10, 2013 |
December 9, 2016 |
December 15, 2021 |
January 24, 2013 |
April 13, 2018 |
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...)
|
| 34 |
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, Senior) |
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...)
|
| 35 |
NCT01200758 |
Active, not recruiting
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, Senior) |
NCT01200758 |
BO22334
2010-021377-36 |
|
February 15, 2011 |
June 12, 2012 |
November 3, 2017 |
September 14, 2010 |
June 26, 2017 |
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...)
|
| 36 |
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, Senior) |
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...)
|
| 37 |
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, Senior) |
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...)
|
| 38 |
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, Senior) |
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...)
|
| 39 |
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, Senior) |
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...)
|
| 40 |
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 |
18 Years and older (Adult, Senior) |
NCT03472040 |
BCX7353-204 |
APeX-S |
February 19, 2018 |
August 2019 |
August 2019 |
March 21, 2018 |
April 3, 2018 |
|
- Study Center
Vienna, Austria - Study Center
Odense, Denmark - Study Center
Frankfurt, Germany - (and 4 more...)
|
| 41 |
NCT03466411 |
Not yet 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, Senior) |
NCT03466411 |
CR108387
2017-002195-13
CNTO1959CRD3001 |
GALAXI |
April 13, 2018 |
June 3, 2022 |
October 23, 2024 |
March 15, 2018 |
April 9, 2018 |
|
- Advanced Research Center Inc
Anaheim, California, United States - Om Research LLC
Lancaster, California, United States - Inland Empire Liver Foundation
Rialto, California, United States - (and 332 more...)
|
| 42 |
NCT03303313 |
Recruiting |
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...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT03303313 |
ALN-CC5-004 |
|
September 19, 2017 |
April 2020 |
November 2020 |
October 6, 2017 |
February 23, 2018 |
|
- Clinical Trial Site
Sarajevo, Bosnia and Herzegovina - Clinical Trial Site
Tallinn, Estonia - Clinical Trial Site
Tartu, Estonia - (and 8 more...)
|
| 43 |
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 2 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03240133 |
BCX7353-202 |
|
July 31, 2017 |
October 2018 |
November 2018 |
August 4, 2017 |
April 17, 2018 |
|
- Study Center
Graz, Austria - Study Center
Odense, Denmark - Study Center
Grenoble, France - (and 21 more...)
|
| 44 |
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, Senior) |
NCT03023020 |
ECRI-009 |
MASTER DAPT |
April 4, 2017 |
October 2019 |
October 2019 |
January 18, 2017 |
March 19, 2018 |
|
- Research Centre Manama
Manama, Bahrain - Research Center Aalst
Aalst, Belgium - Research Center Bonheiden
Bonheiden, Belgium - (and 48 more...)
|
| 45 |
NCT03021499 |
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...)
|
324 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03021499 |
AUR-VCS-2016-01 |
AURORA |
May 17, 2017 |
December 2019 |
March 2020 |
January 16, 2017 |
April 9, 2018 |
|
- AURORA Investigative Center
Huntsville, Alabama, United States - AURORA Investigative Center
Phoenix, Arizona, United States - AURORA Investigative Center
Phoenix, Arizona, United States - (and 170 more...)
|
| 46 |
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, Senior) |
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...)
|
| 47 |
NCT01973244 |
Completed |
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency |
- Growth Hormone Disorder
- Growth Hormone Deficiency in Children
|
- Drug: NNC0195-0092
- 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 2013 |
November 2014 |
November 2014 |
October 31, 2013 |
March 26, 2015 |
|
- Linz, Austria
- Brussels, Belgium
- Paris, France
- (and 5 more...)
|
| 48 |
NCT02828683 |
Active, not recruiting |
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, Senior) |
NCT02828683 |
T120E4 |
MASTER |
July 2013 |
July 2016 |
May 2018 |
July 12, 2016 |
October 18, 2016 |
|
- Sociedad Assistencial Bandeirantes / Hospital Bandeirantes
Liberdade, Brazil - Hospital De Pesquisa Beneficência Portuguesa
São Paolo, Brazil - Instituto Dante Pazzanese
São Paulo, Brazil - (and 12 more...)
|
| 49 |
NCT02735044 |
Active, not recruiting |
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...)
|
450 |
All |
6 Years to 17 Years (Child) |
NCT02735044 |
EFC13957
2015-002084-42
U1111-1168-4546 |
EDITION JUNIOR |
September 22, 2005 |
June 20, 2018 |
December 19, 2018 |
April 12, 2016 |
February 22, 2018 |
|
- 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...)
|
| 50 |
NCT02514447 |
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, Senior) |
NCT02514447 |
G1T28-03
2016-004611-13 |
|
July 2015 |
December 2018 |
May 2019 |
August 3, 2015 |
March 1, 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...)
|
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