NCT00414687已完成2 期
An Explorative, Open-Label, Multicenter, Randomized, Parallel-Group Comparative Study of Safety, Tolerability, and the Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension Over 2 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 63
- 主要终点
- Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange
研究概览
简要总结
The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Secondary pulmonary hypertension
- •Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
- •Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study
排除标准
- •Clinical Instability at baseline
- •Pulmonary venous obstruction
- •Global respiratory insufficiency
- •Obstructive ventilation disorders, Interstitial pulmonary disease
- •Cerebrovascular events
- •Myocardial infarction or major cardiac surgery within 3 months prior to baseline
- •Bleeding disorders or bleeding risk
- •Severe hepatic insufficiency or renal insufficiency
- •Malignant diseases
- •HIV positive
- •Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers
- •Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension
- •Prior pulmonary embolism
- •Collagenosis
- •Pulmonary arterial or valvular stenosis
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ventavis (Iloprost, BAYQ6256) (Drug)
结局指标
主要结局
Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange
Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
次要结局
- Overall clinical tolerability of the long-term use of iloprost aerosol
- Serious Adverse Events and deaths
- Effect of long-term administration of inhaled iloprost on mortality and transplantation
- Exercise capacity
- Acute effect of inhaled iloprost on hemodynamics and gas exchange
- Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
- Quality of Life
研究者
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