NCT02382016已完成4 期
A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension
Actelion51 个研究点 分布在 7 个国家目标入组 85 人开始时间: 2015年6月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 51
- 主要终点
- Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).
研究概览
简要总结
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of at least 18 years of age
- •Confirmed diagnosis of portopulmonary hypertension
排除标准
- •Severe hepatic impairment
- •Severe obstructive or restrictive lung disease
- •Pulmonary veno-occlusive disease
- •Systolic blood pressure (SBP) < 90 mmHg at Screening
- •ALT/AST >= 3 x ULN
- •Bilirubin >= 3 mg/dL at Screening
- •Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results
研究组 & 干预措施
Investigational treatment
Experimental
Macitentan film-coated tablet 10 mg once daily.
干预措施: Macitentan (Drug)
Placebo
Placebo Comparator
Matching placebo tablet once daily.
干预措施: Placebo (Other)
结局指标
主要结局
Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).
时间窗: From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period
The relative change from baseline to Week 12 in PVR is expressed as a ratio of Week 12 to baseline PVR.
次要结局
- Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in Cardiac Index(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in WHO Functional Class (FC)(From enrollment/baseline to Week 12 in the DB treatment period)
- Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)(From enrollment/baseline to Week 12 in the DB treatment period)
研究者
研究点 (51)
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