drugset / Trial / NCT00709098

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

NCT00709098

Phase 3 Completed 49 enrolled Actelion
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2008-09
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Iloprost Other / unclassified 5 ug