Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
3期
进行中（已停止招募）
NCT02562235
| 适应症 | Hypertension, Pulmonary |
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| 分期 | 3期 |
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| 申办方 | Bayer |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 24 人 |
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| 干预（药物） | Riociguat (Adempas, BAY63-2521) |
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| 开始日期 | 2015年10月29日 |
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| 完成日期 | 2020年3月7日 |
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| 结果公布日 | 2021年5月17日 |
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摘要
This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study design consisted of a main study part followed by an optional long-term extension part. The main treatment period consisted of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.
Number of Participants With Any Treatment-emergent Adverse Events
From start of study drug up to 2 days after the last dose of study drug in the main study part, up to 24 weeks plus/minus 5 days. · Participants
| Riociguat >=6 to <18 Years | 20 Participants |
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| Riociguat >=6 to <18 Years | 4 Participants |
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Change in Heart Rate From Baseline
Baseline and Week 24 (plus/minus 5 days) · Beats per minute (BPM)
| Riociguat >=6 to <18 Years | 4.1 ± 10.1 Beats per minute (BPM) |
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Change in Blood Pressure From Baseline
Baseline and Week 24 (plus/minus 5 days) · millimetre of mercury (mmHg)
| Riociguat >=6 to <18 Years | -3.1 ± 10.5 millimetre of mercury (mmHg) |
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| Riociguat >=6 to <18 Years | -2.4 ± 10.0 millimetre of mercury (mmHg) |
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