NCT00345774已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Short-Term Efficacy and Safety of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 38
- 主要终点
- Systolic Pulmonary Artery Pressure
研究概览
简要总结
This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
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
- Double
入排标准
- 年龄范围
- 25 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 to 79 years old.
- •Provide voluntary written informed consent to participate.
- •Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
- •Diagnosis of chronic obstructive pulmonary disease.
- •Become short of breath with physical activity.
- •Elevated systolic pulmonary artery pressures.
- •Not pregnant, nursing, or planning a pregnancy.
排除标准
- •Left ventricular ejection fraction <30%.
- •Heart attack or stroke within the last 6 months.
- •History of lung resection surgery.
- •Use of supplemental oxygen >20 hours/day.
- •Blood donation or significant blood loss within the last 56 days.
- •Plasma donation within the last 14 days.
- •Use of any drugs for another research study within the last 30 days.
- •Use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
- •Positive blood screen Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
- •Major surgery within the last 28 days.
- •Any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
结局指标
主要结局
Systolic Pulmonary Artery Pressure
次要结局
- Safety
- 6 minute walk distance
- Borg Dyspnea Index
- BDI/TDI
- Echocardiograms
- Spirometry
- Oxygen saturation
- WHO functional classification
研究者
研究点 (38)
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