A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
研究概览
简要总结
This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension
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 (Participant, Investigator)
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
- •Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to World Conference on Pulmonary Hypertension classification (Venice, 2003).
- •Symptoms with a WHO class of II-IV
排除标准
- •Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study
- •Chronic inhaled nitric oxide therapy from start to study completion
- •Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine),
- •Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm.
- •Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension
- •Acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease
- •Severe (systemic) arterial hypertension (> 200 mmHg (systolic) or > 120 mmHg (diastolic)) Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
STI571
STI571
干预措施: Imatinib mesylate (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
All Patients
Open label extension
干预措施: Imatinib mesylate (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
时间窗: 6 months
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
时间窗: 72 months
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
时间窗: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation.
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
时间窗: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
时间窗: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.
次要结局
- Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion)
- Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
- Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
- Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
- Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
- Borg Score During the Six Minutes Walk Test at Different Time Periods(Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
- Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Heart Rate (HR) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Cardiac Output (CO) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - PaO2 at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - PaCO2 at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - PvO2 at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - Venous Saturation at Baseline and Study Completion(Baseline, and Study completion (Week 24))
- Blood Gas Measurement - pH at Baseline and Study Completion(Baseline, and Study completion (Week 24))