Trials / Terminated
TerminatedNCT03068130
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bardoxolone methyl | Capsules of Bardoxolone methyl |
Timeline
- Start date
- 2017-04-18
- Primary completion
- 2020-09-30
- Completion
- 2020-09-30
- First posted
- 2017-03-01
- Last updated
- 2025-06-11
- Results posted
- 2023-10-12
Locations
96 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Germany, Israel, Japan, Mexico, Netherlands, Philippines, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03068130. Inclusion in this directory is not an endorsement.