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NCT03019185 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT03019185 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 187 participants.
The verdict
NCT03019185, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Bardoxolone Methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2020-10-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03019185
The ClinicalTrials.gov registry entry for NCT03019185 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 187 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 Oral Capsule is the first listed.
NCT03019185 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03019185 about?
NCT03019185 is a clinical study titled "A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL". This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blin...
What is the current status of trial NCT03019185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2017-03-02. Estimated completion is 2020-10-30.
What interventions are being tested in trial NCT03019185?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Bardoxolone Methyl (DRUG).
Who is sponsoring clinical trial NCT03019185?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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