Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
第3相
実施中（募集終了）
NCT02562235
| 対象疾患 | Hypertension, Pulmonary |
|---|
| 相 | 第3相 |
|---|
| スポンサー | Bayer |
|---|
| ステータス | 実施中（募集終了） |
|---|
| 参加者数 | 24 名 |
|---|
| 介入（薬剤） | Riociguat (Adempas, BAY63-2521) |
|---|
| 開始日 | 2015年10月29日 |
|---|
| 完了日 | 2020年3月7日 |
|---|
| 結果公開日 | 2021年5月17日 |
|---|
概要
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 |
|---|
| Riociguat >=6 to <18 Years | 4 Participants |
|---|
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) |
|---|
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) |
|---|
| Riociguat >=6 to <18 Years | -2.4 ± 10.0 millimetre of mercury (mmHg) |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。