EUCTR2009-010703-80-DE进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
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.Signed informed consent prior to initiation of any study mandated procedure,
- •2.Male or female >= 18 years of age,
- •3.Patients with symptomatic idiopathic, familial pulmonary arterial hypertension or pulmonary arterial hypertension associated with HIV or drugs/toxins (APAH) in New York Heart Association (NYHA) functional class II to IV at baseline,
- •4.6-minute walk distance (6MWD) >= 150 m and <= 450 m at baseline,
- •5.Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization within 3 years prior to randomization and showing:
- •Mean pulmonary artery pressure (mPaP) >= 25 mmHg at rest,
- •Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) < 15 mmHg,
- •Pulmonary vascular resistance (PVR) at rest > = 240 dyn-sec/cm5.
- •6.Patients naïve to PAH treatment, or on a stable dose regimen of bosentan, ambrisentan, or sildenafil, monotherapy for at least 4 weeks prior to randomization (no dosage adjustment should have occurred during this period),
- •7.Women of childbearing potential must use an adequate method of contraception during the study.
- •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
- •1.Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- •2.Pulmonary arterial hypertension associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
- •3.Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
- •4.Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
- •5.Any condition other than PAH, which might affect the patient’s ability to perform a 6-minute walk test (6MWT),
- •6.Pregnant or breast-feeding women,
- •7.Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
- •8.Systolic blood pressure < 95 mmHg,
- •9.Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- •10.Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 µmol/L) or ongoing dialysis,
- •11.Clinically relevant bleeding disorder or active bleeding,
- •12.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening,
- •13.HIV seropositive with any of the following:
- •Active opportunistic infections within 3 months prior to randomization
- •Changes in antiretroviral regimen within 3 months of randomization
- •Using inhaled pentamidine
- •14.For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
- •15.Treatment with another investigational drug within 30 days prior to randomization,
- •16.Use of inhaled Iloprost within the last 6 months,
- •17.Inability to use the inhalation device.
- •18.Known hypersensitivity to iloprost or any of its excipients.
研究者
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