Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01712997
Status:
UNKNOWN
Last Update Posted:
2014-02-27
First Post:
2012-10-22
Brief Title:
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Sponsor:
Air Force Military Medical University China
Organization:
Air Force Military Medical University China
Study Overview
Official Title:
Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
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:
BIPH
Brief Summary:
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension PAH However all of these studies are sequential combination therapy for example by adding sildenafil to previously prescribed bosentan This kind of therapy model is not enough for PAH patients especially those with New York Heart Association NYHA class Ⅲ and Ⅳ In this randomized multicenter study the investigators evaluate the safety and efficacy of combining inhaled iloprost a prostacyclin analog with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy Efficacy endpoints include change from baseline in 6-min-walk distance 6-MWD modified NYHA functional class hemodynamic parameters and time to clinical worsening
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