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
Concentration
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.Patients with symptomatic idiopathic, familial pulmonary arterial hypertension or pulmonary hypertension associated with HIV or drugs/toxins (APAH) in NYHA functional class II to IV who have completed study AC-063A301, 3.Women of childbearing potential* with a negative urine pre-treatment pregnancy test and who consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of =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.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 4.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.Known hypersensitivity to iloprost or any of its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and tolerability of inhaled iloprost delivered by power disc-15 or power disc-6 up to 12 weeks treatment in patients with symptomatic PAH. ;Secondary Objective: To compare the inhalation times of inhaled iloprost delivered by I-neb using the power disc-15 or power disc-6 up to 12 weeks treatment in patients with symptomatic PAH.;Primary end point(s): •Treatment-emergent adverse events (AEs) from the first inhalation of study drug to the day before the end of 12-week treatment period or up to last inhalation in case of early discontinuation •Treatment-emergent serious adverse events (SAEs) from the first inhalation of study drug to the day before the end of 12-week treatment period or up to last inhalation in case of early discontinuation •AEs leading to premature discontinuation of study drug. | — |
Countries
Austria
Outcome results
None listed