drugset / Trial / NCT03068130

Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

NCT03068130 ↗

Phase 3 Terminated 261 enrolled Biogen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-04-18
Primary completion
2020-09-30
Completion
2020-09-30

Outcome

Outcome not reported

Stopped: “The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 10 mg Oral