Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
2상
완료
NCT02036970
| 대상 질환 | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia |
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| 임상 단계 | 2상 |
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| 스폰서 | Biogen |
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| 상태 | 완료 |
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| 참여자 수 | 166 명 |
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| 중재(약물) | Bardoxolone methyl |
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| 시작일 | 2014년 5월 31일 |
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| 완료일 | 2018년 1월 19일 |
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| 결과 공개일 | 2021년 7월 23일 |
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요약
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
Baseline through Week 16 · meters
| Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label | 32.5 ± 29.14 meters |
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| Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label | 24 ± 30.08 meters |
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| Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label | 3.4 ± 31.28 meters |
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| Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label | -3.2 ± 39.53 meters |
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| Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg | 20.3 ± 13.08 meters |
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| Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg | 24.6 ± 59.4 meters |
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| p-value | 0.8133 |
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| Mean Difference (Net) | -1.74 (95% CI -16.22–12.74) |
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BENITIONS에서 보기
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