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NCT02657356 · ClinicalTrials.gov registry record · Phase 3
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT02657356: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT02657356 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02657356, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.
Interventions
- DRUG Placebo capsules
- DRUG Bardoxolone methyl capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2016-10-04 |
| Est. Completion | 2020-05-07 |
| Phase | Phase 3 |
Why NCT02657356 stopped before completion
NCT02657356 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT02657356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02657356 about?
NCT02657356 is a clinical study titled "Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST". This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 week...
What is the current status of trial NCT02657356?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2016-10-04. Estimated completion is 2020-05-07.
What interventions are being tested in trial NCT02657356?
The interventions under investigation include: Placebo capsules (DRUG), Bardoxolone methyl capsules (DRUG).
Who is sponsoring clinical trial NCT02657356?
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 NCT02657356's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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