An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths
研究概览
简要总结
This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.
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
- 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
- •Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
- •Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments
排除标准
- •Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A
- •If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
- •LVEF < 45%
- •Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)
- •Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg
- •Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Core imatinib
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
干预措施: Imatinib (Drug)
Core imatinib
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
干预措施: Placebo (Drug)
Core placebo
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
干预措施: Imatinib (Drug)
Core placebo
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
时间窗: 204 weeks
Adverse event monitoring was conducted throughout the study.
次要结局
- Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)(core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks)
- Percentage of Participants With Incidence of Clinical Worsening Events(204 weeks)