EUCTR2005-002844-24-IT进行中（未招募）不适用
A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ELI LILLY
- 入组人数
- 350
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
- •Subject discontinues the placebo-controlled study (LVGY) due to clinical worsening and is on placebo, tadalafil 2.5mg, 10 mg or 20 mg.
- •Subject completes week 16 in the placebo-controlled study (LVGY) and has one of the following:
- •-no clinical worsening
- •-clinical worsening at the Week 16 Visit and is receiving plcebo, tadalafil 2.5 mg, 10 mg or 20 mg.
- •Female subject with a negative urine pregnancy test at screening Visit
- •Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •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
- •-nursing or pregnant
- •-have left sided heart disease
- •-have a systolic blood pressure < 90mm Hg or diastolic blood pressure <50 mm Hg
- •-have history of Angina pectoris
- •-have musculoskeletal disorder
- •-have a history of symptomatic coronary disease
- •-Have a history of HIV infection
- •-current treatment with antiretroviral therapy
- •-current treatment with prostacyclin or analogue
- •-investigator site personnel directly affiliated with the study
- •-employed by Lilly or ICOS.
研究者
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