A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extensio

• Conditions: Indication: Symptomatic Pulmonary Arterial Hypertension; MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension

• Registration Number: EUCTR2009-011013-24-AT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

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 <1% (oral hormonal contraceptive, implant, vaginal hormone ring, or intrauterine system [IUS]), during the entire study duration and for at least 1 month after last study drug intake. Their partner, if not vasectomised, must use a condom in addition.

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

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) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,

5.Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,

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.Known hypersensitivity to iloprost or any of its excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified