Iloprost Power 15 in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Iloprost

Criteria

Inclusion Criteria:

• Signed informed consent prior to initiation of any study mandated procedure,

• Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.

• 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:

• Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,

• 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,

• 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,

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

• Pregnant or breast-feeding women,

• Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),

• Systolic blood pressure < 95 mmHg,

• Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,

• Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,

• Clinically relevant bleeding disorder or active bleeding,

• For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,

• Known hypersensitivity to iloprost or any of its excipients.