NCT02223494终止2 期
An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 主要终点
- Number of patients with clinically significant findings in laboratory tests
研究概览
简要总结
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who
- •completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
- •provide informed consent to participate in this trial
- •are in a stable or improving medical condition, in the opinion of the investigator
- •enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim
排除标准
- •Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
- •Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
- •Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
研究组 & 干预措施
Terbogrel
Experimental
干预措施: Terbogrel (Drug)
结局指标
主要结局
Number of patients with clinically significant findings in laboratory tests
时间窗: up to 18 months
Number of patients with adverse events
时间窗: up to 18 months
Number of patients with clinically significant changes in ECG
时间窗: up to 18 months
次要结局
- Change in patient status(baseline, up to 18 months)
研究者
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