EUCTR2005-006192-13-IT进行中（未招募）1 期
A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria Age 18-80 years, of either gender PAH due to IPAH, FPAH, connective tissue disease, HIV infection, repaired 8805; 1 year ASD, VSD, or PDA, or druginduced e.g. anorexigens Previous documentation of PAH by right heart catheterization within the prior 3 years demonstrating mPAP 25mmHg at rest, PCWP 8804;15mmHg and PVR 8805; 240 dynes sec cm-5 6-MWD between 100-425 meters at screening On a stable dose of sildenafil for at least 12 weeks prior to screening at a dose between 20 and 80 mg TID
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria Any treatment for PAH with prostacyclins, prostacyclin analogues, PDE-5 inhibitors other than sildenafil, or endothelin-1 antagonists within the past 12 weeks. Pulmonary hypertension due to conditions other than as stated in inclusion criteria. Additional PAH medications added within the past 12 weeks
研究者
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