A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 3
- 主要终点
- Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
研究概览
简要总结
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
imatinib mesylate
Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
干预措施: imatinib mesylate (Drug)
Placebo
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
时间窗: 24 weeks
This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
次要结局
- Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases(24 weeks)
- Change From Baseline in Right Atrial Pressure(baseline and week 24)
- Change From Baseline in Mean Pulmonary Arterial Pressure(baseline and week 24)
- Change From Baseline in Mean Pulmonary Capillary Wedge Pressure(baseline and week 24)
- Change From Baseline in Systemic Vascular Resistance(baseline and week 24)
- Change From Baseline in Pulmonary Vascular Resistance(baseline and week 24)
- Change From Baseline in Pulmonary Resistance Index(baseline and week 24)
- Change From Baseline in Cardiac Output(24 weeks)
- Change From Baseline in Systolic Arterial Blood Pressure(baseline and week 24)
- Change From Baseline in Diastolic Arterial Blood Pressure(baseline and week 24)
- Change From Baseline in Heart Rate(24 weeks)
- Change in Borg Dyspnea Score During 6-minute Walk Test(week 24)
- Covariance of End of Study CAMPHOR Score(Week 24)
- Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant(predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168)
- Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant(predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168)