NCT02223481已完成2 期
A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Change in distance walked in 6 minutes
研究概览
简要总结
This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III
- •Ability to walk >= 50 meters on the 6 minute walk test
- •Resting mean pulmonary artery pressure > 25 mmHg
- •Mean right atrial pressure <= 20 mmHg
- •Pulmonary capillary wedge pressure <= 15 mmHg
- •Cardiac index > 2.5 L/min2
- •SvO2 sat. > 63%
- •Male of female at least 18 years old
- •Signed written informed consent
排除标准
- •Secondary pulmonary hypertension due to lung or systemic diseases
- •Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control
- •Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)
- •Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks
- •History of bleeding diathesis or a platelet count less than 70,000/mm3
- •Exercise limited by factors other than fatigue or exertional dyspnea, such as arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial asthma
- •Myocardial infarction, stroke, or transient ischemic attack within the preceding six months
- •Systolic blood pressure < 90 mmHg or > 180 mmHg, or diastolic blood pressure > 110 mmHg
- •Known drug or alcohol dependency within one year of entry into the study
- •Known hypersensitivity to any component of the study formulation, epoprostenol, nitric oxide, or adenosine
- •Psychiatric or other illness or condition which, in the opinion of the principal investigator, may interfere with study participation, compliance, or other elements of the protocol
- •Participation in an evaluation of an investigational drug within the past 30 days
- •Portal hypertension or cirrhosis of the liver
- •Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not exclude patient from the study
- •Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of serotonin uptake known to be associated with primary pulmonary hypertension, received within 3 months of entry into the study
- •HIV positive
- •Vasodilators. Patients will not receive Ca-channel blockers during the study unless the medication was started prior to the study and the patient has been on a stable dose for at least one month prior to entry
研究组 & 干预措施
Terbogrel low dose
Experimental
干预措施: Terbogrel low dose (Drug)
Terbogrel high dose
Experimental
干预措施: Terbogrel high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in distance walked in 6 minutes
时间窗: baseline, after 3 months of treatment
Change in pulmonary vascular resistance (PVR)
时间窗: baseline, after 3 months of treatment
次要结局
- Change in quality of life by SF-36 questionnaire(baseline, after 3 months of treatment)
- Change in pulmonary artery pressure (PAP)(baseline, after 3 months of treatment)
- Change in chronic heart failure index(baseline, after 3 months of treatment)
- Change in cardiac index (CI)(baseline, after 3 months of treatment)
- Change in venous oxygen saturation (SvO2 sat.)(baseline, after 3 months of treatment)
- Change in dyspnea/fatigue rating(baseline, after 3 months of treatment)
研究者
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