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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03068130|
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : August 28, 2019
|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)|
|Estimated Enrollment :||414 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|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
|Contact: Lacey Powers||(972) firstname.lastname@example.org|