EUCTR2004-003236-59-GB进行中（未招募）1 期
Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
nited Therapeutics Corporation0 个研究点目标入组 220 人开始时间: 2005年6月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
入选标准
- •Clinically stable male or female 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 between 200 and 450 meters with following conditions.
- •Previous cardiac catheterization consistent 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 >3 mmHg/L/min. Within the past 12 months patients must have had a chest radiograph consistent with the diagnosis of PAH. Able to understand and willing to sign the Informed Consent Form.
- •Have been on a stable course of 125 mg of bosentan bid or a stable dose of sildenafil for at least 3 months
- •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
- •Pulmonary venous hypertension, (PVOD), pulmonary capillary haemangiomatosis (PCH), severe COPD, congenital pulmonary hypertension or chronic thromboembolic pulmonary hypertension or any acute concomitant disease; Cogenital heart defect or cogenital 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 medication; hemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids; new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, excepting anticoagulants; preexisting disease known to cause pulmonary hypertension (e.g., obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension); musculoskeletal disease or any other disease that would limit ambulation.
研究者
相似试验
进行中（未招募）
1 期
Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.EUCTR2004-003236-59-BEnited Therapeutics Corporation220
进行中（未招募）
不适用
Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.EUCTR2004-003236-59-DEnited Therapeutics Corporation220
进行中（未招募）
不适用
Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.EUCTR2004-003236-59-ATnited Therapeutics Corporation220
进行中（未招募）
不适用
Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.YHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)EUCTR2004-003236-59-IEung Rx Inc.165
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 HypertensioYHA Class III and IV patients with severe Pulmonary Arterial HypertensioMedDRA version: 14.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2004-003236-59-ITnited Therapeutics Corporation220