Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
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|ClinicalTrials.gov Identifier: NCT02657356|
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : February 14, 2018
|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 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)|
|Estimated Enrollment :||200 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|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Placebo Comparator: Placebo capsules
Placebo capsules will be administered orally once a day for 24 weeks.
|Drug: Placebo capsules|
Experimental: Bardoxolone methyl capsules
Bardoxolone methyl capsules will be administered orally once a day for 24 weeks. Starting dosage 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657356
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