Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Trade Name: Ventavis
Product Name: Iloprost
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Iloprost
CAS Number: 78919-13-8
Concentration unit: µg/ml microgram(s)/millilitre
Concentratio
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 25 mmHg at rest, •Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) = 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
Exclusion criteria
Exclusion criteria: 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) 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement), 8.Systolic blood pressure 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. •To evaluate the safety and tolerability of a single dose of iloprost power 15. ;Primary end point(s): 6MWD after a single dose of iloprost power 15 or placebo. A mean difference of 12.5 m between iloprost power 15 and placebo is to be detected. Assumptions: •The difference in 6MWD between placebo and iloprost power 15 is normally distributed with standard deviation (SD) 30 m. •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. •Patients do not prematurely discontinue the study due to reasons that might be related to the treatments. | — |
Countries
Austria, Germany
Outcome results
None listed