Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
Фаза 2
Завершено
NCT02036970
| Заболевание | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia |
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| Фаза | Фаза 2 |
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| Спонсор | Biogen |
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| Статус | Завершено |
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| Участники | 166 участн. |
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| Вмешательство | Bardoxolone methyl |
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| Дата начала | 31.05.2014 |
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| Дата завершения | 19.01.2018 |
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| Публикация результатов | 23.07.2021 |
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Кратко
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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