Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
|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: NCT02657356|
Recruitment Status : Terminated (Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health)
First Posted : January 15, 2016
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Connective Tissue Disease-Associated Pulmonary Arterial Hypertension||Drug: Placebo capsules Drug: Bardoxolone methyl capsules||Phase 3|
This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with World Health Organization Group I Connective Tissue Disease Pulmonary Arterial Hypertension (WHO Group I CTD-PAH).
Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Patients randomized to placebo will remain on placebo throughout the study. Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically. Dose de-escalation is permitted during the study if indicated clinically.
All patients in the study will follow the same visit and assessment schedule. Following randomization, patients will be scheduled to be assessed in person during treatment at Weeks 1, 2, 4, 6, 8, 16, and 24 and by telephone contact on Days 3, 10, 21, 31, 38, 84, and 140. Patients will also be scheduled to be assessed at an in person follow up visit at Week 28, four weeks after the end of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension|
|Actual Study Start Date :||October 4, 2016|
|Actual Primary Completion Date :||May 7, 2020|
|Actual Study Completion Date :||May 7, 2020|
Placebo Comparator: Placebo capsules
Placebo capsules will be administered orally once a day for 24 weeks.
Drug: Placebo capsules
Experimental: Bardoxolone methyl capsules
Each patient will receive bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient is 5 mg and will dose-escalate to 10 mg at Week 4, unless contraindicated clinically.
Drug: Bardoxolone methyl capsules
Other Name: RTA 402 capsules
- Change from baseline in six-minute-walk distance (6MWD) [ Time Frame: 24 weeks ]
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): NCT02657356