Ignite Creation Date:
2024-05-05 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00709956
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2008-07-01
Brief Title:
Iloprost Power 15 in Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROWESS 15
Brief 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 drugstoxins 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None