NCT01172756终止2 期
Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 39
- 主要终点
- Pulmonary artery mean pressure at rest
研究概览
简要总结
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction
排除标准
- •Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
研究组 & 干预措施
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Riociguat (BAY63-2521) (Drug)
Arm 2
Experimental
干预措施: Riociguat (BAY63-2521) (Drug)
Arm 3
Experimental
干预措施: Riociguat (BAY63-2521) (Drug)
结局指标
主要结局
Pulmonary artery mean pressure at rest
时间窗: Peak change from baseline within 6 hours after a single dose of study drug
次要结局
- Adverse event collection(until 30 days after study drug treatment)
- Plasma concentrations to obtain pharmacokinetic profile of Riociguat(Within 24 hours after study drug treatment)
研究者
相似试验
进行中（未招募）
不适用
Riociguat single -dose study measuring of blood flow in lungs with high blood pressure associated with heart failure.Pulmonary hypertension associated with diastolic heart failureMedDRA version: 13.1Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018436-41-CZBayer HealthCare AG48
进行中（未招募）
不适用
Riociguat single -dose study measuring of blood flow in lungs with high blood pressure associated with heart failure.EUCTR2010-018436-41-ATBayer HealthCare AG48
进行中（未招募）
不适用
Riociguat single -dose study measuring of blood flow in lungs with high blood pressure associated with heart failure.EUCTR2010-018436-41-DEBayer HealthCare AG48
终止
2 期
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic DysfunctionHypertension, PulmonaryVentricular Dysfunction, LeftNCT01065454Bayer202
已完成
2 期
Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection FractionHypertension, PulmonaryHeart Failure With Normal Ejection FractionNCT02744339Medical University of Vienna118