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NCT02036970 · ClinicalTrials.gov registry record · Phase 2
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT02036970: Completed Phase 2 study, sponsored by Biogen.
NCT02036970 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02036970, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study Summary
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.
Primary Outcome
Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.
Interventions
- DRUG Placebo
- DRUG Bardoxolone methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2018-05-16 |
| Phase | Phase 2 |
What the finished NCT02036970 record still lists
NCT02036970 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02036970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02036970 about?
NCT02036970 is a clinical study titled "Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT". This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypert...
What is the current status of trial NCT02036970?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2014-05-31. Estimated completion is 2018-05-16.
What interventions are being tested in trial NCT02036970?
The interventions under investigation include: Placebo (DRUG), Bardoxolone methyl (DRUG).
Who is sponsoring clinical trial NCT02036970?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02036970's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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