NCT02070991已完成2 期
A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Actelion32 个研究点 分布在 11 个国家目标入组 63 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 32
- 主要终点
- Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
研究概览
简要总结
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females >=18 years of age
- •Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
- •Optimized diuretic therapy
排除标准
- •Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
- •Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
研究组 & 干预措施
Macitentan
Experimental
oral tablet, 10 mg once daily.
干预措施: Macitentan (Drug)
Placebo
Placebo Comparator
Matching placebo, once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
时间窗: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
次要结局
- PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest(From randomization up to end of treatment period (Week 12))
- Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)(From randomization up to end of treatment period (Week 12))
- Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)(From randomization up to end of treatment period (Week 12))
- NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest(From randomization up to end of treatment period (Week 12))
- Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)(From randomization up to end of treatment period (Week 12))
- Change From Baseline to Week 12 in Cardiac Index (CI)(From randomization up to end of treatment period (Week 12))
- Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)(From randomization up to end of treatment period (Week 12))
研究者
研究点 (32)
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