Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 106
- 主要终点
- The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline.
研究概览
简要总结
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- •Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
- •No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)
排除标准
- •Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
研究组 & 干预措施
Group 1
干预措施: Iloprost (Ventavis, BAYQ6256) (Drug)
结局指标
主要结局
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline.
时间窗: Month 3 Visit
次要结局
- Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.(all scheduled visits (Study period is min. 2 years and max. 4 years))
- Other safety variables (optional assessment)(At all scheduled visits (Study period is min. 2 years and max. 4 years))
- Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL.(all scheduled visits (Study period is min. 2 years and max. 4 years))
- Other safety variable(At all scheduled visits (Study period is min. 2 years and max. 4 years))
- Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline.(all scheduled visits (Study period is min. 2 years and max. 4 years))
- The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.(all scheduled visits (Study period is min. 2 years and max. 4 years))