Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
3상
진행 중(모집 완료)
NCT02562235
| 대상 질환 | Hypertension, Pulmonary |
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| 임상 단계 | 3상 |
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| 스폰서 | Bayer |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 24 명 |
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| 중재(약물) | Riociguat (Adempas, BAY63-2521) |
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| 시작일 | 2015년 10월 29일 |
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| 완료일 | 2020년 3월 7일 |
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| 결과 공개일 | 2021년 5월 17일 |
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요약
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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