| 1 |
NCT02941926 |
Recruiting |
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC |
|
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Goserelin
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The number of participants with adverse events as a measure of safety and tolerability
- Time-to-Progression (TTP)
- Overall response rate (ORR) for patients with measurable disease
- (and 2 more...)
|
3775 |
All |
18 Years and older (Adult, Older Adult) |
NCT02941926 |
CLEE011A2404 |
|
November 29, 2016 |
November 22, 2019 |
November 22, 2019 |
October 21, 2016 |
October 19, 2018 |
|
- Ironwood Cancer and Research Centers
Chandler, Arizona, United States - Arizona Oncology Associates Arizona Oncology Assoc. (2)
Tucson, Arizona, United States - Highlands Oncology Group
Fayetteville, Arkansas, United States - (and 526 more...)
|
|
| 2 |
NCT01093482 |
Completed
Has Results |
Third International Study on Mechanical Ventilation |
- Acute Respiratory Failure
|
|
Observational
|
|
- Hospital Universitario Getafe
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
8151 |
All |
18 Years and older (Adult, Older Adult) |
NCT01093482 |
ISMV-2010 |
ISMV |
April 2010 |
July 2010 |
September 2010 |
March 25, 2010 |
March 1, 2018 |
January 26, 2018 |
- University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States - University of Louisville School of Medicine
Louisville, Kentucky, United States - Boston Medical Center
Boston, Massachusetts, United States - (and 474 more...)
|
|
| 3 |
NCT01147250 |
Completed
Has Results |
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) |
|
- Drug: Lixisenatide (AVE0010)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
- Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
- Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure
- Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108
|
6068 |
All |
30 Years and older (Adult, Older Adult) |
NCT01147250 |
EFC11319
2009-012852-26
U1111-1116-5558 |
ELIXA |
June 2010 |
February 2015 |
February 2015 |
June 22, 2010 |
December 20, 2016 |
October 14, 2016 |
- Investigational Site Number 840415
Birmingham, Alabama, United States - Investigational Site Number 840307
Foley, Alabama, United States - Investigational Site Number 840692
Mobile, Alabama, United States - (and 826 more...)
|
|
| 4 |
NCT00366249 |
Completed
Has Results |
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis. |
- Bacterial Infections
- Diabetic Foot
- Osteomyelitis
|
- Drug: Tigecycline
- Drug: Ertapenem
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of Patients With Clinical Response of Cure Vs. Failure.
- Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
- Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
- (and 2 more...)
|
1061 |
All |
18 Years and older (Adult, Older Adult) |
NCT00366249 |
3074K5-319 |
|
January 2007 |
March 2009 |
March 2009 |
August 21, 2006 |
April 28, 2010 |
August 21, 2009 |
- Los Angeles, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- (and 208 more...)
|
|
| 5 |
NCT02595814 |
Active, not recruiting |
Global Non-interventional Heart Failure Disease Registry |
|
|
Observational
|
|
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- Number of patients with different characteristics of heart faliure (HF) at hospitalization
- Percentage of patients who die during the index hospitalization
- Percentage of patients who die during the follow-up period post-discharge
- (and 6 more...)
|
18805 |
All |
18 Years and older (Adult, Older Adult) |
NCT02595814 |
CRPORTHF |
REPORT-HF |
July 23, 2014 |
July 23, 2020 |
July 23, 2020 |
November 3, 2015 |
November 27, 2017 |
|
- Novartis Investigative Site
San Diego, California, United States - Novartis Investigative Site
San Francisco, California, United States - Novartis Investigative Site
Chicago, Illinois, United States - (and 348 more...)
|
|
| 6 |
NCT01126437 |
Completed
Has Results |
Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease |
- Pulmonary Disease, Chronic Obstructive
|
- Drug: tiotropium 18 mcg
- Drug: tiotropium 1.25 mcg (2 actuations/day)
- Drug: tiotropium 2.5 mcg (2 actuations/day)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Time to All-Cause Mortality
- Time to First COPD Exacerbation
- Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)
- (and 6 more...)
|
17183 |
All |
40 Years and older (Adult, Older Adult) |
NCT01126437 |
205.452
2009-015713-51 |
|
May 2010 |
May 2013 |
May 2013 |
May 19, 2010 |
June 20, 2014 |
June 20, 2014 |
- 205.452.01107 Boehringer Ingelheim Investigational Site
Athens, Alabama, United States - 205.452.01023 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 205.452.01035 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - (and 1188 more...)
|
|
| 7 |
NCT00699998 |
Completed
Has Results |
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects |
|
- Drug: Clopidogrel
- Drug: Prasugrel
- Drug: Commercially-available Aspirin
|
Interventional
|
Phase 3 |
- Eli Lilly and Company
- Daiichi Sankyo Co., Ltd.
- Duke Clinical Research Institute
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
- Percentage of Participants With a Composite Endpoint of CV Death and MI
- Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
- (and 7 more...)
|
9326 |
All |
18 Years and older (Adult, Older Adult) |
NCT00699998 |
11058
H7T-MC-TABY(b) |
TRILOGY ACS |
June 2008 |
April 2012 |
April 2012 |
June 18, 2008 |
May 7, 2013 |
May 7, 2013 |
- 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.
Huntsville, 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 - (and 685 more...)
|
|
| 8 |
NCT00580216 |
Terminated |
Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation |
|
- Drug: Idrabiotaparinux sodium
- Drug: Warfarin
- Drug: Placebo (for idrabiotaparinux)
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)
- Components of the primary study outcome measure:
- Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death
|
3773 |
All |
18 Years and older (Adult, Older Adult) |
NCT00580216 |
EFC10295
2007-004817-33 |
BOREALIS-AF |
December 2007 |
October 2010 |
October 2010 |
December 24, 2007 |
March 21, 2016 |
|
- Sanofi-Aventis Investigational Site Number 840227
Mobile, Alabama, United States - Sanofi-Aventis Investigational Site Number 840209
Tucson, Arizona, United States - Sanofi-Aventis Investigational Site Number 840255
Little Rock, Arkansas, United States - (and 535 more...)
|
|
| 9 |
NCT02322762 |
Active, not recruiting |
DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Anti-diabetic treatments prescribed by physicians in a real-world setting.
- Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.
- Changes in anti-diabetic treatments
- (and 4 more...)
|
14173 |
All |
18 Years and older (Adult, Older Adult) |
NCT02322762 |
D1690R00002 |
DISCOVER |
December 30, 2014 |
June 30, 2019 |
June 30, 2019 |
December 23, 2014 |
June 11, 2018 |
|
- Research Site
Alger, Algeria - Research Site
Algiers, Algeria - Research Site
Batna, Algeria - (and 368 more...)
|
|
| 10 |
NCT02226120 |
Completed |
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction |
- Chronic Heart Failure With Reduced Ejection Fraction
|
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with adverse events of special interest
|
2007 |
All |
Child, Adult, Older Adult |
NCT02226120 |
CLCZ696B2317
2014-001971-30 |
|
October 16, 2014 |
December 28, 2017 |
December 28, 2017 |
August 27, 2014 |
October 15, 2018 |
|
- Novartis Investigative Site
Huntsville, Alabama, United States - Novartis Investigative Site
Muscle Shoals, Alabama, United States - Novartis Investigative Site
Little Rock, Arkansas, United States - (and 394 more...)
|
|
| 11 |
NCT01663727 |
Completed
Has Results |
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer |
|
- Drug: Bevacizumab [Avastin]
- Drug: Paclitaxel
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population
- Progression Free Survival (PFS) in ITT Population
- Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population
- (and 10 more...)
|
481 |
All |
18 Years and older (Adult, Older Adult) |
NCT01663727 |
GO25632
2011-005335-97 |
|
August 27, 2012 |
November 30, 2014 |
November 30, 2017 |
August 13, 2012 |
May 14, 2018 |
February 10, 2016 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Arizona Cancer Center
Tucson, Arizona, United States - Wilshire Oncology Medical Group
Corona, California, United States - (and 175 more...)
|
|
| 12 |
NCT01887600 |
Completed |
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis |
- Anemia in Chronic Kidney Disease in Non-dialysis Patients
|
- Drug: Roxadustat
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Astellas Pharma Europe B.V.
- FibroGen
- Astellas Pharma Inc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Hemoglobin (Hb) response to treatment with Roxadustat without the use of rescue therapy
- Change in Hb from Baseline (BL) to the average level regardless of rescue therapy
- Hb maintenance: Hb change from BL to the average Hb, without having received rescue therapy within 6 weeks prior to and during the 8-week evaluation period (weeks 28 to 36)
- (and 48 more...)
|
597 |
All |
18 Years and older (Adult, Older Adult) |
NCT01887600 |
1517-CL-0608
2012-005180-27 |
ALPS |
September 3, 2013 |
November 1, 2017 |
November 1, 2017 |
June 27, 2013 |
November 24, 2017 |
|
- Site BY37503
Brest, Belarus - Site BY37504
Gomel, Belarus - Site BY37501
Grodno, Belarus - (and 135 more...)
|
|
| 13 |
NCT01358877 |
Active, not recruiting
Has Results |
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer |
|
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- (and 7 more...)
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Genentech, Inc.
- Breast International Group
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
- Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
- Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
- (and 27 more...)
|
4804 |
All |
18 Years and older (Adult, Older Adult) |
NCT01358877 |
BO25126
TOC4939G
2010-022902-41
BIG 4-11 |
APHINITY |
November 8, 2011 |
December 19, 2016 |
December 1, 2023 |
May 24, 2011 |
August 31, 2018 |
January 5, 2018 |
- Mayo Clinic Arizona
Scottsdale, Arizona, United States - HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States - NEA Baptist Clinic
Jonesboro, Arkansas, United States - (and 596 more...)
|
|
| 14 |
NCT01610037 |
Completed
Has Results |
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation |
- Chronic Obstructive Pulmonary Disease (COPD)
|
- Drug: QVA149
- Drug: Tiotropium
- Drug: placebo
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Patients With Serious Adverse Events
- Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
- Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
- (and 9 more...)
|
1215 |
All |
40 Years and older (Adult, Older Adult) |
NCT01610037 |
CQVA149A2339
2012-002057-38 |
|
October 2012 |
February 2015 |
February 2015 |
June 1, 2012 |
June 15, 2016 |
June 15, 2016 |
- Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
Caba, Buenos Aires, Argentina - (and 113 more...)
|
|
| 15 |
NCT01528254 |
Active, not recruiting |
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus |
|
- Drug: Placebo to vildagliptin
- Drug: vildagliptin
- Drug: Metformin
|
Interventional
|
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rate of loss in glycemic control over time
- Time to initial treatment failure
- Rate of loss in glycemic control in fasting plasma glucose
- (and 5 more...)
|
2005 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01528254 |
CLAF237A23156
2011-003712-23 |
|
November 3, 2011 |
April 8, 2019 |
April 18, 2019 |
February 7, 2012 |
October 16, 2018 |
|
- Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
San Isidro, Buenos Aires, Argentina - (and 238 more...)
|
|
| 16 |
NCT01318941 |
Completed |
Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting |
- Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- Wet Age Related Macular Degeneration
- Diabetic Macular Edema
- Retinal Vein Occlusion
|
- Drug: Ranibizumab
- Other: Ranibizumab
|
Observational
|
|
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Mean Visual Acuity (VA) and mean change in VA
- Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
- Mean visual acuity at quarterly intervals for the primary treated eye set
- (and 5 more...)
|
30490 |
All |
Child, Adult, Older Adult |
NCT01318941 |
CRFB002A2406 |
LUMINOUS |
March 2011 |
April 2016 |
April 2016 |
March 21, 2011 |
May 23, 2016 |
|
- Novartis Investigative Site
Lanus, Buenos Aires, Argentina - Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina - Novartis Investigative Site
Rosario, Santa Fe, Argentina - (and 460 more...)
|
|
| 17 |
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...)
|
|
| 18 |
NCT01035255 |
Terminated
Has Results |
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure |
- Heart Failure With Reduced Ejection Fraction
|
- Drug: LCZ696 200 mg BID
- Drug: Enalapril 10 mg BID
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
- Number of Patients - All-cause Mortality
- Number of Patients Reported With Adjudicated Primary Causes of Death
- (and 3 more...)
|
8442 |
All |
18 Years and older (Adult, Older Adult) |
NCT01035255 |
CLCZ696B2314
2009-015834-31 |
PARADIGM-HF |
December 2009 |
May 2014 |
May 2014 |
December 18, 2009 |
August 15, 2016 |
September 7, 2015 |
- Novartis Investigative Site
Birmingham, Alabama, United States - Novartis Investigative Site
Birmingham, Alabama, United States - Novartis Investigative Site
Huntsville, Alabama, United States - (and 1027 more...)
|
|
| 19 |
NCT00407537 |
Completed
Has Results |
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors |
- Hypertension
- Hypercholesterolemia
|
- Drug: Amlodipine besylate/atorvastatin calcium single pill combination
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
- Framingham 10-year Risk of Total CHD at Month 4
- European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
- (and 19 more...)
|
1531 |
All |
35 Years to 79 Years (Adult, Older Adult) |
NCT00407537 |
A3841047 |
CRUCIAL |
March 2007 |
October 2009 |
October 2009 |
December 5, 2006 |
July 23, 2015 |
November 11, 2011 |
- Pfizer Investigational Site
Desamparados, San Jose, Costa Rica - Pfizer Investigational Site
Heredia, Costa Rica - Pfizer Investigational Site
San Jose, Costa Rica - (and 123 more...)
|
|
| 20 |
NCT00490971 |
Completed
Has Results |
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder |
|
- Drug: Olanzapine
- Drug: Paliperidone ER
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder
- Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder
- Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder
|
768 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00490971 |
CR010825
R076477BIM3004 |
|
May 2006 |
April 2010 |
April 2010 |
June 25, 2007 |
April 15, 2015 |
March 5, 2012 |
- Scottsdale, Arizona, United States
- Riverside, California, United States
- San Diego, California, United States
- (and 77 more...)
|
|
| 21 |
NCT01168791 |
Completed |
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma |
|
- Drug: doxorubicin in combination with palifosfamide-tris
- Drug: doxorubicin in combination with placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression Free Survival followed by Overall Survival
- Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
- Safety and Tolerability as evaluated using CTCAE v 4.0
|
447 |
All |
18 Years and older (Adult, Older Adult) |
NCT01168791 |
IPM3001 |
PICASSO III |
July 2010 |
March 2013 |
March 2013 |
July 23, 2010 |
July 18, 2013 |
|
- Birmingham, Alabama, United States
- Arizona Oncology Associates
Phoenix, Arizona, United States - Scottsdale, Arizona, United States
- (and 159 more...)
|
|
| 22 |
NCT00543725 |
Completed
Has Results |
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors |
|
- Drug: TMC278
- Drug: efavirenz
|
Interventional
|
Phase 3 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48
- Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48
- Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96
- (and 6 more...)
|
680 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT00543725 |
CR002704
TMC278-TIDP6-C215 |
|
June 2008 |
January 2010 |
February 2012 |
October 15, 2007 |
April 1, 2016 |
July 12, 2011 |
- Long Beach, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- (and 81 more...)
|
|
| 23 |
NCT00130897 |
Approved for marketing |
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma |
|
|
Expanded Access
|
|
|
Industry |
|
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00130897 |
A6181037 |
|
July 2005 |
November 2011 |
November 2011 |
August 16, 2005 |
March 9, 2012 |
|
- Pfizer Investigational Site
Scottsdale, Arizona, United States - Pfizer Investigational Site
San Francisco, California, United States - Pfizer Investigational Site
San Francisco, California, United States - (and 271 more...)
|
|
| 24 |
NCT02467907 |
Active, not recruiting |
Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel for Metastatic, Recurrent or Persistent Cervical Cancer |
|
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Paclitaxel
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants with GI Perforation/Fistula Events by Grade According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
- Percentage of Participants with GI-Vaginal Fistula Events by Grade According to NCI-CTCAE Version 4.0
- Percentage of Participants with GU Fistula Events by Grade According to NCI-CTCAE Version 4.0
- (and 17 more...)
|
152 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02467907 |
MO29594
2014-005491-28 |
|
July 28, 2015 |
December 31, 2018 |
December 31, 2018 |
June 10, 2015 |
September 7, 2018 |
|
- Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina - Hospital das Clinicas - UFMG
Belo Horizonte, MG, Brazil - Oncologica Brasil S/S LTDA - EPP
Belem, PA, Brazil - (and 40 more...)
|
|
| 25 |
NCT03523858 |
Recruiting |
A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis |
- Progressive Multiple Sclerosis (PMS)
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants with No Evidence of Progression (NEP)
- Proportion of Participants with NEP Sustained For At Least 24 Weeks and No Active Disease (NEPAD)
- Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)
- (and 20 more...)
|
600 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03523858 |
MN39159 |
CONSONANCE |
May 28, 2018 |
September 29, 2023 |
January 31, 2024 |
May 14, 2018 |
October 3, 2018 |
|
- MS Center of California
Newport Beach, California, United States - Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States - University of South Florida
Tampa, Florida, United States - (and 109 more...)
|
|
| 26 |
NCT02425891 |
Active, not recruiting |
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) |
- Triple Negative Breast Cancer
|
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
- Drug: Nab-Paclitaxel
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in all Randomized Participants
- PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
- Overall Survival (OS) in all Randomized Participants
- (and 12 more...)
|
900 |
All |
18 Years and older (Adult, Older Adult) |
NCT02425891 |
WO29522
2014-005490-37 |
|
June 23, 2015 |
April 17, 2018 |
April 30, 2020 |
April 24, 2015 |
September 25, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Katmai Oncology
Anchorage, Alaska, United States - HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States - (and 300 more...)
|
|
| 27 |
NCT03191799 |
Recruiting |
A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence and severity of all adverse events (AEs) including thromboembolic events, microangiopathic hemolytic anemia or TMA (e.g. hemolytic uremic syndrome), systemic hypersensitivity, anaphylaxis, and anaphylactoid events
- Numbers of bleeds over time
- Hemophilia Adult Quality of Life Questionnaire (Haem-A-QoL) (>= 18 y)
- (and 8 more...)
|
200 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03191799 |
MO39129
2016-004366-25 |
STASEY |
September 5, 2017 |
September 4, 2020 |
September 4, 2020 |
June 19, 2017 |
October 15, 2018 |
|
- Royal Prince Alfred Hospital; Haematology
Camperdown, New South Wales, Australia - Alfred Hospital
Melbourne, Victoria, Australia - Fiona Stanley Hospital
Murdoch, Western Australia, Australia - (and 81 more...)
|
|
| 28 |
NCT01966471 |
Active, not recruiting |
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer |
|
- Drug: Trastuzumab Emtansine
- Drug: Trastuzumab
- Drug: Pertuzumab
- (and 6 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Invasive Disease-Free Survival (IDFS) in the Overall Population
- IDFS in the Node-Positive Subpopulation
- IDFS Plus Second Primary Non-Breast Cancer
- (and 8 more...)
|
1846 |
All |
18 Years and older (Adult, Older Adult) |
NCT01966471 |
BO28407
2012-004902-82 |
|
January 31, 2014 |
January 31, 2024 |
January 31, 2024 |
October 21, 2013 |
September 24, 2018 |
|
- Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States - HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States - Kaiser Permanente - Oakland
Oakland, California, United States - (and 338 more...)
|
|
| 29 |
NCT01566721 |
Active, not recruiting
Has Results |
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
- Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
- Percentage of Participants With Treatment Interruption Due to an AE
- (and 8 more...)
|
2577 |
All |
18 Years and older (Adult, Older Adult) |
NCT01566721 |
MO28048
2011-005328-17 |
SafeHER |
May 17, 2012 |
March 10, 2015 |
March 3, 2020 |
March 29, 2012 |
September 12, 2018 |
April 18, 2017 |
- University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania - CPMC; Service d'Oncologie Médicale
Algiers, Algeria - Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, Argentina - (and 480 more...)
|
|
| 30 |
NCT01716754 |
Completed
Has Results |
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma |
|
- Drug: QGE031
- Drug: Omalizumab
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
- Change From Baseline in ACQ-7 Score
- Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
- (and 2 more...)
|
471 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01716754 |
CQGE031B2201
2012-002298-69 |
|
December 2012 |
January 2016 |
January 2016 |
October 30, 2012 |
August 11, 2017 |
March 8, 2017 |
- Novartis Investigative Site
Fresno, California, United States - Novartis Investigative Site
Hawaiian Gardens, California, United States - Novartis Investigative Site
Riverside, California, United States - (and 147 more...)
|
|
| 31 |
NCT01610414 |
Completed
Has Results |
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A |
|
- Biological: Herpes Zoster vaccine GSK1437173A
- Biological: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
- Duration of 'Worst' HZ-associated Pain
- Number of Subjects With Confirmed HZ-associated Complications
- (and 9 more...)
|
1877 |
All |
18 Years and older (Adult, Older Adult) |
NCT01610414 |
115523
2012-000138-20 |
|
July 13, 2012 |
November 4, 2016 |
February 1, 2017 |
June 4, 2012 |
January 23, 2018 |
January 23, 2018 |
- GSK Investigational Site
Duarte, California, United States - GSK Investigational Site
San Francisco, California, United States - GSK Investigational Site
Aurora, Colorado, United States - (and 175 more...)
|
|
| 32 |
NCT01444430 |
Completed
Has Results |
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents |
|
- Drug: Symbicort pMDI
- Drug: budesonide pMDI
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
- Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
- Percent of Days With no Asthma Symptoms
- (and 5 more...)
|
12460 |
All |
12 Years to 130 Years (Child, Adult, Older Adult) |
NCT01444430 |
D5896C00027
2011-002790-28 |
|
December 2011 |
October 2015 |
October 2015 |
September 30, 2011 |
December 15, 2016 |
December 15, 2016 |
- Research Site
Birmingham, Alabama, United States - Research Site
Huntsville, Alabama, United States - Research Site
Anchorage, Alaska, United States - (and 347 more...)
|
|
| 33 |
NCT01767467 |
Completed
Has Results |
Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers |
|
- Biological: Herpes zoster vaccine (GSK 1437173A)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
- Adjusted Geometric Mean Concentration of Anti-gE Antibodies
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms
- (and 14 more...)
|
568 |
All |
18 Years and older (Adult, Older Adult) |
NCT01767467 |
116428
2012-003438-18 |
|
March 1, 2013 |
January 7, 2016 |
January 6, 2017 |
January 14, 2013 |
June 5, 2018 |
May 25, 2017 |
- GSK Investigational Site
Inverness, Florida, United States - GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Elkhart, Indiana, United States - (and 83 more...)
|
|
| 34 |
NCT01419717 |
Completed |
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer |
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer
- Bone Metastases in Subjects With Advanced Breast Cancer
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Subject incidence of treatment-emergent adverse events
- Subject incidence of anti-denosumab antibodies
|
129 |
All |
18 Years and older (Adult, Older Adult) |
NCT01419717 |
20110113 |
|
November 22, 2011 |
August 10, 2018 |
August 10, 2018 |
August 18, 2011 |
August 31, 2018 |
|
- Research Site
Capital Federal, Buenos Aires, Argentina - Research Site
Quilmes, Buenos Aires, Argentina - Research Site
Cordoba, Córdoba, Argentina - (and 61 more...)
|
|
| 35 |
NCT01232569 |
Completed
Has Results |
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis |
|
- Drug: Tocilizumab 162 mg
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24
- Percentage of Patients With ACR50 and ACR70 Responses at Week 24
- Time to Onset of ACR20, ACR50, and ACR70 Responses
- (and 14 more...)
|
656 |
All |
18 Years and older (Adult, Older Adult) |
NCT01232569 |
NA25220
2010-019912-18 |
|
March 2011 |
May 2012 |
November 2013 |
November 2, 2010 |
July 29, 2015 |
October 23, 2013 |
- Peoria, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- (and 138 more...)
|
|
| 36 |
NCT01201356 |
Active, not recruiting |
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis |
- Relapsing Forms of Multiple Sclerosis
|
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Long-term safety & tolerability of fingolimod 0.5 mg/day in patients with relapsing forms of MS
- Long-term efficacy of fingolimod 0.5 mg/day in patients with relapsing forms of MS
|
4125 |
All |
18 Years and older (Adult, Older Adult) |
NCT01201356 |
CFTY720D2399
2010-020515-37 |
|
September 13, 2010 |
September 28, 2018 |
October 2, 2018 |
September 14, 2010 |
October 5, 2018 |
|
- Novartis Investigative Site
Cullman, Alabama, United States - Novartis Investigative Site
Oceanside, California, United States - Novartis Investigative Site
Sacramento, California, United States - (and 454 more...)
|
|
| 37 |
NCT02008227 |
Active, not recruiting
Has Results |
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy |
- Non-Squamous Non-Small Cell Lung Cancer
|
- Drug: Atezolizumab
- Drug: Docetaxel
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Died: PP-ITT
- Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
- Overall Survival (OS): PP-ITT
- (and 27 more...)
|
1225 |
All |
18 Years and older (Adult, Older Adult) |
NCT02008227 |
GO28915
2013-003331-30 |
OAK |
March 11, 2014 |
July 7, 2016 |
December 31, 2018 |
December 11, 2013 |
September 19, 2018 |
July 2, 2017 |
- Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States - Roy & Patricia Disney Family Cancer Center
Burbank, California, United States - St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States - (and 215 more...)
|
|
| 38 |
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...)
|
|
| 39 |
NCT01450696 |
Terminated
Has Results |
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer |
|
- Drug: Capecitabine
- Drug: Cisplatin
- Drug: Herceptin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Died - FAS
- Overall Survival - FAS
- Percentage of Participants Who Died - Per Protocol Set (PPS)
- (and 6 more...)
|
296 |
All |
18 Years and older (Adult, Older Adult) |
NCT01450696 |
BO27798
2011-001526-19 |
HELOISE |
December 2011 |
February 2015 |
August 2015 |
October 12, 2011 |
November 28, 2016 |
November 28, 2016 |
- La Jolla, California, United States
- Los Angeles, California, United States
- Whittier, California, United States
- (and 114 more...)
|
|
| 40 |
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...)
|
|
| 41 |
NCT01641939 |
Terminated
Has Results |
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer |
|
- Drug: Taxane
- Drug: trastuzumab emtansine
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS)- Phase 3
- Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)
- Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
- (and 14 more...)
|
415 |
All |
18 Years and older (Adult, Older Adult) |
NCT01641939 |
BO27952
2012-000660-22 |
|
September 3, 2012 |
June 30, 2015 |
April 30, 2016 |
July 17, 2012 |
May 12, 2017 |
August 11, 2016 |
- Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States - Stanford University School of Medicine
Stanford, California, United States - Yale Cancer Center
New Haven, Connecticut, United States - (and 145 more...)
|
|
| 42 |
NCT01041404 |
Completed
Has Results |
ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer |
|
- Drug: Trastuzumab
- Drug: Fluorouracil
- Drug: Cisplatin
- Drug: Capecitabine
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Chugai Pharmaceutical
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS) - Percentage of Participants With an Event
- Overall Survival - Time to Event
- Progression-Free Survival (PFS) - Percentage of Participants With an Event
- (and 16 more...)
|
584 |
All |
18 Years and older (Adult, Older Adult) |
NCT01041404 |
BO18255 |
|
September 2005 |
June 2010 |
June 2010 |
December 31, 2009 |
November 5, 2014 |
November 5, 2014 |
- Adelaide, Australia
- Kurralta Park, Australia
- Melbourne, Australia
- (and 139 more...)
|
|
| 43 |
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 |
|
June 10, 2013 |
December 9, 2016 |
December 15, 2021 |
January 24, 2013 |
July 10, 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...)
|
|
| 44 |
NCT01287741 |
Completed
Has Results |
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) |
- Diffuse Large B-Cell Lymphoma
|
- Drug: Rituximab
- Drug: Obinutuzumab
- Drug: Cyclophosphamide
- (and 3 more...)
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Fondazione Italiana Linfomi ONLUS
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS), Investigator-Assessed
- Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
- Overall Survival (OS)
- (and 13 more...)
|
1418 |
All |
18 Years and older (Adult, Older Adult) |
NCT01287741 |
BO21005
2010-024194-39 |
|
July 31, 2011 |
April 29, 2016 |
January 31, 2018 |
February 1, 2011 |
August 1, 2018 |
August 17, 2017 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States - Arizona Oncology
Tucson, Arizona, United States - (and 232 more...)
|
|
| 45 |
NCT00949910 |
Completed
Has Results |
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) |
- Non-Small Cell Lung Cancer
|
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
- Percentage of Participants With Disease Control According to RECIST
- Percentage of Participants by Best Overall Response According to RECIST
- (and 4 more...)
|
6586 |
All |
18 Years and older (Adult, Older Adult) |
NCT00949910 |
MO18109
2004-000564-28
INC-9042 |
|
November 2004 |
April 2009 |
April 2009 |
July 31, 2009 |
October 5, 2016 |
October 4, 2016 |
- Tirana, Albania
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- (and 541 more...)
|
|
| 46 |
NCT00950300 |
Completed
Has Results |
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer |
|
- Drug: 5-Fluorouracil
- Drug: Cyclophosphamide
- Drug: Docetaxel
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
- Percentage of Participants With Pathological Complete Response (pCR)
- Observed Ctrough of Trastuzumab After Surgery
- (and 19 more...)
|
596 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00950300 |
BO22227
2008-007326-19 |
|
October 16, 2009 |
July 12, 2011 |
January 24, 2017 |
July 31, 2009 |
January 23, 2018 |
January 23, 2017 |
- Centro Medico San Roque; Oncology Dept
Tucuman, Argentina - Caipo; Oncology
Tucuman, Argentina - Hospital Sao Rafael - HSR
Salvador, BA, Brazil - (and 103 more...)
|
|
| 47 |
NCT01234311 |
Completed |
A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer |
|
- Drug: tasquinimod
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer
|
1245 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01234311 |
10TASQ10 |
|
March 2011 |
February 2015 |
August 2015 |
November 4, 2010 |
October 21, 2015 |
|
- Tucson, Arizona, United States
- Oxnard, California, United States
- Santa Monica, California, United States
- (and 202 more...)
|
|
| 48 |
NCT01662869 |
Completed |
A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer |
|
- Drug: 5-Fluoruracil
- Drug: Folinic acid
- Drug: Onartuzumab
- (and 2 more...)
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Genentech, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
- OS in the Intent-To-Treat (ITT) Population
- Duration of Response, as Assessed by Investigator Using RECIST v1.1
- (and 13 more...)
|
564 |
All |
18 Years and older (Adult, Older Adult) |
NCT01662869 |
YO28322
2012-001402-23 |
|
November 2012 |
December 2015 |
December 2015 |
August 10, 2012 |
November 2, 2016 |
|
- Los Angeles, California, United States
- Denver, Colorado, United States
- Fort Myers, Florida, United States
- (and 122 more...)
|
|
| 49 |
NCT00802841 |
Completed
Has Results |
Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib |
- Chronic Myelogenous Leukemia
|
- Drug: nilotinib
- Drug: imatinib
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Complete Cytogenetic Response (CCyR)
- Percentage of Participants With Major Molecular Response (MMR)
- Percentage of Participants With CCyr
- (and 5 more...)
|
191 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00802841 |
CAMN107A2404
2008-007054-35 |
LASOR |
May 2009 |
July 2014 |
July 2014 |
December 5, 2008 |
November 16, 2015 |
November 16, 2015 |
- Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
Caba, Buenos Aires, Argentina - Novartis Investigative Site
La Plata, Buenos Aires, Argentina - (and 53 more...)
|
|
| 50 |
NCT02545283 |
Recruiting |
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) |
|
- Drug: Cytarabine
- Drug: Idasanutlin
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Overall Survival in TP53 WT Population
- Overall Survival in the Overall Population
- Percentage of Participants in CR at the End of Induction According to Hematologic Malignancy Response Assessment (HMRA) in TP53 WT Population
- (and 23 more...)
|
440 |
All |
18 Years and older (Adult, Older Adult) |
NCT02545283 |
WO29519
2014-003065-15 |
MIRROS |
December 30, 2015 |
December 10, 2019 |
May 26, 2021 |
September 9, 2015 |
October 1, 2018 |
|
- Northwell Health
Great Neck, New York, United States - New York Medical College
Hawthorne, New York, United States - Ichan School of Medicine at Mount Sinai
New York, New York, United States - (and 96 more...)
|
|
| 51 |
NCT00720798 |
Completed
Has Results |
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies |
|
- Drug: Tocilizumab
- Drug: Disease-modifying anti-rheumatic drugs
- Drug: Non-steroidal anti-inflammatory drugs
- Drug: Oral corticosteroids
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With ≥ 1 Adverse Event
- Percentage of Participants Who Withdrew From Treatment
- Percentage of Participants With Concomitant Oral Corticosteroid Therapy
- (and 13 more...)
|
2067 |
All |
18 Years and older (Adult, Older Adult) |
NCT00720798 |
WA18696 |
|
September 2005 |
April 2013 |
April 2013 |
July 23, 2008 |
September 30, 2014 |
September 30, 2014 |
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Mesa, Arizona, United States
- (and 292 more...)
|
|
| 52 |
NCT00781612 |
Recruiting |
A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies |
|
- Drug: Docetaxel
- Drug: Paclitaxel
- Drug: Pertuzumab
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Genentech, Inc.
- Hoffmann-La Roche
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction
|
720 |
All |
Child, Adult, Older Adult |
NCT00781612 |
TDM4529g
BO25430
2010-021067-32 |
|
October 16, 2008 |
September 21, 2022 |
September 21, 2022 |
October 29, 2008 |
September 24, 2018 |
|
- City of Hope National Medical Center
Duarte, California, United States - Can Care Assoc Med Group Inc; Beach Cities Offices
Los Angeles, California, United States - Comp Cancer Centers of Nevada
Los Angeles, California, United States - (and 200 more...)
|
|
| 53 |
NCT02563054 |
Completed |
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer |
|
- Drug: 5-Fluorouracil
- Drug: Capecitabine
- Drug: Cisplatin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to disease progression
- Objective tumor response rate
- Overall survival
- (and 3 more...)
|
316 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02563054 |
ML17032 |
|
April 2003 |
August 2010 |
August 2010 |
September 29, 2015 |
November 2, 2016 |
|
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Rosario, Argentina
- (and 42 more...)
|
|
| 54 |
NCT00537238 |
Completed
Has Results |
Pregabalin Versus Levetiracetam In Partial Seizures |
|
- Drug: pregabalin
- Drug: levetiracetam
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of Participants With Response to Treatment
- Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
- Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
- (and 5 more...)
|
509 |
All |
18 Years and older (Adult, Older Adult) |
NCT00537238 |
A0081157 |
|
October 2007 |
May 2012 |
May 2012 |
October 1, 2007 |
July 11, 2013 |
July 11, 2013 |
- Pfizer Investigational Site
Duffel, Belgium - Pfizer Investigational Site
Yvoir, Belgium - Pfizer Investigational Site
Kyustendil 2500, Bulgaria - (and 70 more...)
|
|
| 55 |
NCT00262067 |
Unknown †
Has Results |
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1) |
|
- Drug: Bevacizumab
- Drug: Placebo
- Drug: Chemotherapy
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
- Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
- Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
- (and 3 more...)
|
1237 |
All |
18 Years and older (Adult, Older Adult) |
NCT00262067 |
AVF3694g
BO20094 |
|
December 2005 |
July 2008 |
December 2013 |
December 6, 2005 |
December 13, 2013 |
October 25, 2013 |
- Fullerton, California, United States
- Santa Barbara, California, United States
- Iowa City, Iowa, United States
- (and 89 more...)
|
|
| 56 |
NCT00088530 |
Completed
Has Results |
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL) |
|
- Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
- Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Response (CR) and Complete Response Unconfirmed (CRu)
- Progression-Free Survival (PFS)
- Overall Survival
- Overall Response Rate (ORR) Lasting at Least 4 Months
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT00088530 |
PIX301 |
|
July 2004 |
February 2010 |
July 2010 |
July 29, 2004 |
June 1, 2017 |
June 1, 2017 |
- Robert A. Moss, M.D., FACP, Inc.
Fountain Valley, California, United States - UCLA Medical Center
Los Angeles, California, United States - Watson Clinic for Cancer Care and Research
Lakeland, Florida, United States - (and 96 more...)
|
|
| 57 |
NCT00258557 |
Completed |
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications. |
|
- Drug: LPV/RTV
- Drug: TMC-114/RTV
|
Interventional
|
Phase 3 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48
- Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment
|
692 |
All |
18 Years and older (Adult, Older Adult) |
NCT00258557 |
CR002800
TMC114-C211 |
|
September 2005 |
June 2007 |
May 2012 |
November 24, 2005 |
June 26, 2013 |
|
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Long Beach, California, United States
- (and 90 more...)
|
|
| 58 |
NCT00239681 |
Terminated
Has Results |
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events |
- Elevated High-sensitivity C-Reactive Protein (hsCRP)
|
- Drug: Rosuvastatin
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
- Time to Death Due to Any Cause
- Time to Non-cardiovascular Death
- (and 3 more...)
|
17802 |
All |
50 Years and older (Adult, Older Adult) |
NCT00239681 |
D3560L00030
Jupiter
4522US/0011 |
|
February 2003 |
September 2008 |
September 2008 |
October 17, 2005 |
March 24, 2014 |
March 24, 2014 |
- Research Site
Birmingham, Alabama, United States - Research Site
Calera, Alabama, United States - Research Site
Columbiana, Alabama, United States - (and 856 more...)
|
|
| 59 |
NCT00141102 |
Completed
Has Results |
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis |
- Osteoarthritis
- Arthritis, Rheumatoid
|
- Drug: Celecoxib
- Drug: Diclofenac + Omeprazole
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
- Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
- Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)
- (and 12 more...)
|
4484 |
All |
18 Years and older (Adult, Older Adult) |
NCT00141102 |
A3191084 |
CONDOR |
October 2005 |
May 2009 |
May 2009 |
September 1, 2005 |
April 21, 2011 |
June 11, 2010 |
- Pfizer Investigational Site
Genk, Belgium - Pfizer Investigational Site
Gent, Belgium - Pfizer Investigational Site
Hasselt, Belgium - (and 192 more...)
|
|
| 60 |
NCT00486759 |
Terminated
Has Results |
A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma |
|
- Drug: Bevacizumab
- Drug: Rituximab
- Drug: CHOP
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Hoffmann-La Roche
- Genentech, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS)
- Overall Survival
- Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma
|
787 |
All |
18 Years to 79 Years (Adult, Older Adult) |
NCT00486759 |
BO20603 |
|
July 26, 2007 |
November 30, 2011 |
November 30, 2011 |
June 15, 2007 |
July 25, 2017 |
December 31, 2012 |
- Uni of California - San Diego; Cancer Center & Dept of Medicine
La Jolla, California, United States - Kenmar Research Inst.
Whittier, California, United States - University of Colorado Cancer Center Department of Hematology
Aurora, Colorado, United States - (and 263 more...)
|
|
| 61 |
NCT00099203 |
Terminated |
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease |
- Pain
- Bone Neoplasm
- Neoplasm Metastasis
|
- Drug: ibandronate [Bondronat]
- Drug: zoledronic acid
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Pain, as measured by Brief Pain Inventory and analgesic use
- Performance score and QoL measures
- AEs and laboratory parameters
- (and 2 more...)
|
163 |
All |
18 Years and older (Adult, Older Adult) |
NCT00099203 |
BO18040 |
|
July 2005 |
December 2007 |
December 2007 |
December 10, 2004 |
August 16, 2017 |
|
- Birmingham, Alabama, United States
- Sedona, Arizona, United States
- Ocoee, Florida, United States
- (and 69 more...)
|
|
| 62 |
NCT00099177 |
Terminated |
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain |
- Pain
- Bone Neoplasm
- Neoplasm Metastasis
|
- Drug: ibandronate [Bondronat]
- Drug: zoledronic acid
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Pain, as measured by Brief Pain Inventory and analgesic use
- Performance score and QoL measures
- AEs and laboratory parameters
- (and 2 more...)
|
96 |
All |
18 Years and older (Adult, Older Adult) |
NCT00099177 |
BO18039 |
|
August 2005 |
December 2007 |
December 2007 |
December 10, 2004 |
August 16, 2017 |
|
- Miami, Florida, United States
- Macon, Georgia, United States
- Houston, Texas, United States
- (and 38 more...)
|
|
| 63 |
NCT00106574 |
Completed |
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis |
|
- Drug: Placebo
- Drug: tocilizumab [RoActemra/Actemra]
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of patients with ACR 20 response
- Percentage of patients with ACR 50 and ACR 70 responses.
- Mean changes in parameters of ACR core set
- AEs, laboratory parameters, vital signs.
|
1220 |
All |
18 Years and older (Adult, Older Adult) |
NCT00106574 |
WA18063 |
|
April 2005 |
December 2007 |
December 2007 |
March 28, 2005 |
November 2, 2016 |
|
- Mesa, Arizona, United States
- Paradise Valley, Arizona, United States
- Peoria, Arizona, United States
- (and 143 more...)
|
|
| 64 |
NCT00110877 |
Completed |
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients |
|
- Drug: LPV/rtv
- Drug: TMC114/rtv
|
Interventional
|
Phase 3 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
- Number of Participants with Adverse Events
- Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
|
604 |
All |
18 Years and older (Adult, Older Adult) |
NCT00110877 |
CR002794
TMC114-C214 |
|
April 2005 |
January 2007 |
October 2011 |
May 16, 2005 |
July 3, 2015 |
|
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- (and 104 more...)
|
|
| 65 |
NCT00393939 |
Completed
Has Results |
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer |
|
- Drug: Sunitinib malate
- Drug: Taxotere
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS)
- Percentage of Participants With Objective Response
- Duration of Response (DR)
- (and 4 more...)
|
594 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00393939 |
A6181064 |
SUN 1064 |
February 2007 |
February 2010 |
July 2011 |
October 31, 2006 |
July 19, 2012 |
February 28, 2011 |
- Pfizer Investigational Site
Berkely, California, United States - Pfizer Investigational Site
Shreveport, Louisiana, United States - Pfizer Investigational Site
Beaumont, Texas, United States - (and 141 more...)
|
|
| 66 |
NCT00090753 |
Completed
Has Results |
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia |
|
- Drug: Methoxy Polyethylene Glycol-Epoetin Beta
- Drug: Epoetin alfa
- Drug: Epoetin beta
- Drug: Darbepoetin alfa
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
- Percentage of Patients Who Had at Least 1 Adverse Event
|
1228 |
All |
18 Years and older (Adult, Older Adult) |
NCT00090753 |
BH18387 |
|
October 2004 |
December 2009 |
December 2009 |
September 6, 2004 |
February 14, 2012 |
January 5, 2012 |
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Montgomery, Alabama, United States
- (and 246 more...)
|
|
| 67 |
NCT00773513 |
Completed
Has Results |
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs) |
|
- Drug: Darbepoetin Alfa
- Drug: Epoetin Alfa
- Drug: Epoetin Beta
- Drug: methoxy polyethylene glycol-epoetin beta
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
- Time to All-Cause Mortality
- Time to Non-Fatal and Fatal Myocardial Infarction
- (and 5 more...)
|
2825 |
All |
18 Years and older (Adult, Older Adult) |
NCT00773513 |
BH21260
2007-005129-31 |
|
December 12, 2008 |
July 27, 2017 |
July 27, 2017 |
October 16, 2008 |
September 19, 2018 |
August 15, 2018 |
- Fresenius Medical Care Martinez
Buenos Aires, Argentina - Fresenius Medical Care Morón
Buenos Aires, Argentina - Fresenius Medical Care San Martin
Buenos Aires, Argentina - (and 193 more...)
|
|
| 68 |
NCT00069095 |
Completed
Has Results |
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer |
|
- Drug: Oxaliplatin 130 mg/m^2
- Drug: Capecitabine 1000 mg/m^2
- Drug: Bevacizumab 7.5 mg/kg
- (and 6 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4
- PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
- PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4
- (and 19 more...)
|
2035 |
All |
18 Years and older (Adult, Older Adult) |
NCT00069095 |
NO16966 |
|
July 2003 |
January 2006 |
April 2009 |
September 18, 2003 |
October 6, 2016 |
January 22, 2016 |
- Berkeley, California, United States
- Fountain Valley, California, United States
- Fullerton, California, United States
- (and 233 more...)
|
|
| 69 |
NCT00069121 |
Completed
Has Results |
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer |
|
- Drug: capecitabine [Xeloda]
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: 5 FU
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free Survival (DFS) [Number of Events]
- Disease-free Survival [Time to Event]
- Relapse-free Survival (RFS) [Number of Events]
- (and 4 more...)
|
1886 |
All |
18 Years and older (Adult, Older Adult) |
NCT00069121 |
NO16968 |
|
January 2003 |
April 2009 |
April 2009 |
September 18, 2003 |
August 22, 2013 |
July 29, 2011 |
- Mobile, Alabama, United States
- Tucson, Arizona, United States
- Tucson, Arizona, United States
- (and 253 more...)
|
|
| 70 |
NCT02721641 |
Completed
Has Results |
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- On-Study Duration of Trial Treatment
- Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
- Number of Participants Withdrawn From Study Because of LVEF Dysfunction
|
69 |
All |
18 Years and older (Adult, Older Adult) |
NCT02721641 |
BO15943
2007-000348-28 |
|
June 1999 |
February 2015 |
February 2015 |
March 29, 2016 |
March 31, 2017 |
March 31, 2017 |
- Liverpool, New South Wales, Australia
- Waratah, New South Wales, Australia
- Brisbane, Queensland, Australia
- (and 38 more...)
|
|
| 71 |
NCT01003990 |
Completed
Has Results |
Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access |
|
- Drug: Atazanavir
- Drug: Atazanavir/Ritonavir
- Drug: Tenofovir/Emtricitabine
- Drug: Lopinavir/ritonavir
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
|
710 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01003990 |
AI424-077 |
|
October 2002 |
February 2016 |
February 2016 |
October 29, 2009 |
May 11, 2017 |
May 11, 2017 |
- Phoenix Body Positive, Inc
Phoenix, Arizona, United States - Rand Schrader Clinic
Los Angeles, California, United States - St Francis Memorial Hospital
San Francisco, California, United States - (and 86 more...)
|
|
| 72 |
NCT00643292 |
Completed |
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections |
|
- Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
- Drug: azithromycin SR
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- clinical response (cure or failure) in the Clinical Per Protocol population
- summary of baseline susceptibilities
- Laboratory abnormalities
- (and 7 more...)
|
902 |
All |
3 Months to 48 Months (Child) |
NCT00643292 |
A0661073 |
|
January 2003 |
|
May 2004 |
March 26, 2008 |
May 17, 2011 |
|
- Pfizer Investigational Site
Jonesboro, Arkansas, United States - Pfizer Investigational Site
Little Rock, Arkansas, United States - Pfizer Investigational Site
Bellflower, California, United States - (and 45 more...)
|
|
| 73 |
NCT00475670 |
Completed
Has Results |
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer |
|
- Drug: Trastuzumab
- Drug: Taxane (docetaxel or paclitaxel)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines
- Duration of Response - Percentage of Participants With Progressive Disease or Death
- Duration of Response
- (and 7 more...)
|
44 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00475670 |
WO17299 |
|
October 2005 |
June 2012 |
June 2012 |
May 21, 2007 |
September 15, 2014 |
September 15, 2014 |
- Geelong, Victoria, Australia
- Klagenfurt, Austria
- Salzburg, Austria
- (and 54 more...)
|
|
| 74 |
NCT00043927 |
Completed |
Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults |
|
- Drug: topotecan/cisplatin
- Drug: etoposide/cisplatin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival
- response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients
|
760 |
All |
18 Years and older (Adult, Older Adult) |
NCT00043927 |
104864-A/389 |
|
April 2001 |
January 2004 |
|
August 16, 2002 |
August 21, 2013 |
|
- GSK Clinical Trials Call Center
Hoover, Alabama, United States - GSK Clinical Trials Call Center
Chula Vista, California, United States - GSK Clinical Trials Call Center
Fountain Valley, California, United States - (and 173 more...)
|
|
| 75 |
NCT00013897 |
Completed |
A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine |
|
- Drug: Atazanavir
- Drug: Lamivudine/Zidovudine
- Drug: Efavirenz
|
Interventional
|
Phase 3 |
|
Industry |
- Masking: Double
- Primary Purpose: Treatment
|
|
|
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00013897 |
302C
AI424-034 |
|
February 2001 |
April 2003 |
April 2003 |
August 31, 2001 |
May 4, 2011 |
|
- Phoenix Body Positive
Phoenix, Arizona, United States - Univ of Southern California
Los Angeles, California, United States - Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States - (and 96 more...)
|
|
| 76 |
NCT03371017 |
Recruiting |
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer |
- Triple Negative Breast Neoplasms
|
- Drug: Atezolizumab
- Drug: Placebo
- Drug: Gemcitabine
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall survival (OS)
- Proportion of patients alive 12 months
- Proportion of patients alive 18 months
- (and 4 more...)
|
350 |
All |
18 Years and older (Adult, Older Adult) |
NCT03371017 |
MO39193
2016-005119-42 |
IMpassion132 |
January 11, 2018 |
July 31, 2019 |
January 31, 2021 |
December 13, 2017 |
October 9, 2018 |
|
- Florida Cancer Specialists & Research Institute
Saint Petersburg, Florida, United States - Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States - The Valley Hospital
Paramus, New Jersey, United States - (and 97 more...)
|
|
| 77 |
NCT02435212 |
Active, not recruiting |
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload |
- Transfusion-dependent Anemia
|
- Drug: Deferasirox granule formulation
- Drug: Deferasirox DT formulation
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Compliance (using stick/pack tablet count).
- Change in serum ferritin in ICT naive patients.
- Compliance (using stick/pack tablet count)
- (and 8 more...)
|
224 |
All |
2 Years to 17 Years (Child) |
NCT02435212 |
CICL670F2202
2013-004739-55 |
|
October 21, 2015 |
May 31, 2018 |
January 19, 2024 |
May 6, 2015 |
October 15, 2018 |
|
- Children's Hospital Oakland Onc Dept
Oakland, California, United States - Childrens Healthcare of Atlanta Onc Dept
Atlanta, Georgia, United States - Lurie Children's Hospital of Chicago Onc Dept
Chicago, Illinois, United States - (and 37 more...)
|
|
| 78 |
NCT00739973 |
Completed
Has Results |
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension |
|
- Drug: Placebo
- Drug: Aliskiren 150 mg tablet
- Drug: Aliskiren 300 mg tablet
- (and 6 more...)
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
- (and 24 more...)
|
2694 |
All |
18 Years and older (Adult, Older Adult) |
NCT00739973 |
CSPA100A2305 |
|
September 2008 |
May 2009 |
May 2009 |
August 22, 2008 |
June 6, 2011 |
May 3, 2011 |
- Investigative Site
East Hanover, New Jersey, United States - Investigative Site
Buenos Aires, Argentina - Invesigative Site
Canberra, Australia - (and 15 more...)
|
|
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