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
- Conditions
- Indication: Symptomatic Pulmonary Arterial HypertensionMedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
- Registration Number
- EUCTR2009-010703-80-DE
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 63
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To demonstrate that a single dose of iloprost power 15 improves exercise capacity in patients with symptomatic pulmonary arterial hypertension.;Secondary Objective: •To evaluate the effect of a single dose of iloprost power 15 on the Borg dyspnea score. <br>•To evaluate the safety and tolerability of a single dose of iloprost power 15.<br>;Primary end point(s): 6MWD after a single dose of iloprost power 15 or placebo.<br>A mean difference of 12.5 m between iloprost power 15 and placebo is to be detected. <br>Assumptions:<br>•The difference in 6MWD between placebo and iloprost power 15 is normally distributed with standard deviation (SD) 30 m. <br>•The period effect is of relevant size, nevertheless it is not depending on the treatment that is administered first; i.e., no carry-over effect. <br>•Patients do not prematurely discontinue the study due to reasons that might be related to the treatments.<br>
- Secondary Outcome Measures
Name Time Method