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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Pulmonary arterial hypertension Hypertension MedlinePlus related topics: Connective Tissue Disorders High Blood Pressure Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Double ( Participant Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment 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 Names: RTA 402 capsules Primary Outcome Measures Outcome Measure Measure Description Time Frame Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24 Baseline through 24 weeks after participant receives the first dose Secondary Outcome Measures Outcome Measure Measure Description Time Frame Time to First Persistent Clinical Improvement Event At least one of the following four criteria must have been met: Improvement by at least one WHO functional class coupled with no more than a 15% decrease from baseline in 6MWT Increase from baseline in 6MWT by at least 10% and stability or improvement in the WHO functional class Decrease from baseline in creatine kinase (a surrogate biomarker for muscle injury and inflammation) by at least 10% and no worsening in WHO functional class and no more than a 15% decrease from baseline in 6MWT Improvement in estimated glomerular filtration rate eGFR ≥10% of baseline The persistence of the change in WHO functional class, 6MWT, eGFR, or creatine kinase must be confirmed by a subsequent assessment at least 14 days after the initial assessment, or at the next scheduled assessment. If persistent improvement is confirmed, the date of the event was considered the initial assessment of improved WHO functional class, 6MWT, eGFR, or creatine kinase. Baseline through the end of the study Keywords Provided by Biogen (Reata, a wholly owned subsidiary of Biogen) Pulmonary Hypertension Pulmonary Arterial Hypertension Connective Tissue Disease-Associated Pulmonary Arterial Hypertension Bardoxolone methyl PAH RTA 402 6-minute walk distance Additional Relevant MeSH Terms Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Connective Tissue Diseases Plan to Share Individual Participant Data (IPD)? Yes IPD Plan Description In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/ IPD Sharing Url https://vivli.org/ Study Documents Provided by Biogen (Reata, a wholly owned subsidiary of Biogen) Study Protocol [ PDF , 1.07MB, 2016-10-18 ] Statistical Analysis Plan [ PDF , 1.08MB, 2020-05-26 ] Revision: v2.9.1'
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