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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 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 202 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02657356
The ClinicalTrials.gov registry entry for NCT02657356 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT02657356 reports 0 study locations.
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.
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