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NCT01766817 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
A Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 325
- Enrollment target
- 20
- Study locations
NCT01766817: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by Bristol-Myers Squibb.
NCT01766817 is a Phase 2 study of Idiopathic Pulmonary Fibrosis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 325 participants, below the 745-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01766817, a Phase 2 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 325 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).
Primary Outcome
FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes.
Conditions Studied
Interventions
- DRUG BMS-986020
- DRUG Placebo matching with BMS-986020
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- David Geffen School of Medicine at UCLA - Los Angeles
- University of California at San Francisco - San Francisco
- Stanford University Medical Center - Stanford
Florida
- Advanced Pulmonary & Sleep Research Institute of Florida - Daytona Beach
- University of Florida - Gainesville
- ILD Research Center - Miami
- Cleveland Clinic Florida- Weston Hospital - Weston
Kentucky
- University of Kentucky- Center for Clinical and Translational Science - Lexington
- University of Louisville - Louisville
Massachusetts
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Alabama
- University of Alabama at Birmingham - Division of Pulmonary, Allergy & Criticial Care - Birmingham
Arizona
- St. Joseph's Hospital and Medical Center - Heart Lung Institute/ Clinical Research - Phoenix
Colorado
- National Jewish Health - Denver
Connecticut
- Yale University School of Medicine, Section of Pulmonary & Critical Care - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2016-02-29 |
| Phase | Phase 2 |
What the finished NCT01766817 record still lists
NCT01766817 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 745-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which BMS-986020 is the first listed.
NCT01766817 names 20 study sites across 12 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01766817 about?
NCT01766817 is a clinical study titled "Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis". The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).
What is the current status of trial NCT01766817?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 2013-01-31. Estimated completion is 2016-02-29.
What conditions does trial NCT01766817 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT01766817?
The interventions under investigation include: BMS-986020 (DRUG), Placebo matching with BMS-986020 (DRUG).
Who is sponsoring clinical trial NCT01766817?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01766817 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01766817's enrollment target sits among peer trials
325 13th of 51 higher than 39 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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