EUCTR2004-003236-59-IT进行中（未招募）不适用
Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension
nited Therapeutics Corporation0 个研究点目标入组 220 人开始时间: 2009年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •Clinically stable male or famale patients of any racial origin with severe PAH (NYHA Class III or Class IV), 18 to 75 years of age, can do an un-encouraged 6 minute walk test of beetween 200 and 450 meters with following conditions. Previous cardiac cathetersation consist with PAH, specifically PAPm greater than or equal to 25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) less than or equal to 15 mmHG, and PVR major than 3 mmHG/L/min. Within the past 12 months patients must have had a chest radiograph consist with the diagnosis of PAH. Able to understand and willing to sign the ICF. HAve been on a stable course of 125mg of bosentan bid or stable dose of sildenafil for at lest 3 months.
- •Are the trial subjects under 18? no
- •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
- •Pulmonary venous hypertension (PVOD), pulmonary capillary haemangiomatosis (PCH), severe COPD, congenital pulmonary hypertension or chronic thromboembolic pulmonary hypertension or any acute concomitant disease; congenital heart defect or congenital heart disease; pregnancy/lactation;change or discontinued any PAH medication within the last 3 months;received within the 30 days before trial or scheduled to receive any prostanoid, PDE5 inhibitors other than sildenafil or any investigational medicine;hemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids
研究者
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