NCT01392495终止3 期
An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events, Serious Adverse Events and Deaths
研究概览
简要总结
This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct
排除标准
- •Patients with left ventricular ejection fraction (LVEF) < 45%
- •Patients with thrombocytopenia, platelet count < 50 x109/L (50 x 103/µL).
- •Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160 mmHg or diastolic pressure > 90 mmHg.
- •Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QTI571
Experimental
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
干预措施: Imatinib (Drug)
结局指标
主要结局
Number of Patients With Adverse Events, Serious Adverse Events and Deaths
时间窗: 144 weeks
Adverse event monitoring was conducted throughout the trial.
次要结局
- Time to Clinical Worsening (TTCW) Endpoints(144 weeks)
- Change From Baseline in the Six Minute Walk Distance (6MWD)(baseline, 144 weeks)
- Medical Resource Utilization(144 weeks)
研究者
研究点 (1)
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