Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
2期
已完成
NCT02036970
| 适应症 | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia |
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| 分期 | 2期 |
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| 申办方 | Biogen |
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| 状态 | 已完成 |
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| 受试者人数 | 166 人 |
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| 干预（药物） | Bardoxolone methyl |
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| 开始日期 | 2014年5月31日 |
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| 完成日期 | 2018年1月19日 |
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| 结果公布日 | 2021年7月23日 |
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摘要
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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