EUCTR2006-004705-26-GB进行中（未招募）1 期
Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology
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
- 12
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
- •1. Patients >18 years with a functional class III (1998 WHO classification).
- •2. Patients with pulmonary arterial hypertension related to Eisenmenger physiology
- •3. Patients with documented oxygen saturation <90%, and >70% (at rest, with room air).
- •4. Patients stable for at least 3 months prior to screening.
- •5. Patients providing written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with left ventricular dysfunction (ejection fraction <40%).
- •2. Patients with systolic blood pressure < 85 mm Hg.
- •3. Patients with other conditions that may affect the ability to perform a 6-minute walk test.
- •4. Patients unable to provide informed consent and comply with the patient protocol.
- •5. Patients with known coronary arterial disease.
- •6. Patients with serum creatinine >125 µM/l.
- •6. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
- •7. Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
- •8. Patients who are receiving vasodilators including, but not limited to epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
- •9. Patients active on organ transplant lists.
- •10. Patients taking phosphodiesterase inhibitors, nitrates or endothelin receptor antagonists
- •11. Patients with planned surgical intervention during the study period.
- •15. Pregnant patients
- •16. Patients treated with potent CYP3A4 inhibitors
研究者
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