Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER (RANGER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03068130|
Recruitment Status : Terminated (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.)
First Posted : March 1, 2017
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Bardoxolone methyl||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension|
|Actual Study Start Date :||April 18, 2017|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||September 30, 2020|
Experimental: Bardoxolone methyl 10 mg
Bardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
Drug: Bardoxolone methyl
Capsules of Bardoxolone methyl
Other Name: RTA 402
- Long-term Safety [ Time Frame: Up to 5 years (December 2021) ]Long-term Safety as Measured by Incidence of Adverse Events During the maximum study duration of 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068130