Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Phase 3
Terminated
NCT03068130
| Condition | Pulmonary Hypertension |
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| Phase | Phase 3 |
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| Sponsor | Biogen |
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| Status | Terminated |
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| Enrollment | 261 participants |
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| Interventions | Bardoxolone methyl |
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| Start date | Apr 18, 2017 |
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| Completion date | Sep 30, 2020 |
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| Results posted | Oct 12, 2023 |
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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.
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
From time of first dose until the final visit, up to 172 weeks · Participants
| Bardoxolone Methyl | 232 Participants |
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| Bardoxolone Methyl | 89 Participants |
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| Bardoxolone Methyl | 106 Participants |
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| Bardoxolone Methyl | 42 Participants |
|---|
| Bardoxolone Methyl | 96 Participants |
|---|
| Bardoxolone Methyl | 94 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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