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NCT03068130 · ClinicalTrials.gov registry record · Phase 3
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
NCT03068130: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT03068130 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 261 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03068130, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
Study Summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Primary Outcome
Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.
Interventions
- DRUG Bardoxolone methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 3 |
Why NCT03068130 stopped before completion
NCT03068130 is an interventional study that assigns participants to a tested intervention. The registered 261 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 (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Bardoxolone methyl is the first listed.
NCT03068130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03068130 about?
NCT03068130 is a clinical study titled "Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER". This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
What is the current status of trial NCT03068130?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2017-04-18. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT03068130?
The interventions under investigation include: Bardoxolone methyl (DRUG).
Who is sponsoring clinical trial NCT03068130?
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 NCT03068130's enrollment target sits among peer trials
261 1228th of 2000 higher than 771 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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