Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: iloprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709098

AC-063A302

Details and patient eligibility

About

Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent prior to initiation of any study mandated procedure,
2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
3. Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.

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 (Pulmonary capillary wedge pressure (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. Pregnant or breast-feeding women,
6. Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
7. Systolic blood pressure < 95 mmHg,
8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
9. Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
10. Clinically relevant bleeding disorder or active bleeding,
11. Known hypersensitivity to iloprost or any of its excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups

iloprost power 6

Active Comparator group

Description:

iloprost power 15

Treatment:

Drug: iloprost

Drug: iloprost

iloprost power 15

Experimental group

Description:

iloprost power 15

Treatment:

Drug: iloprost

Drug: iloprost