Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086463
Status:
COMPLETED
Last Update Posted:
2011-04-01
First Post:
2004-07-01
Brief Title:
Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan Tracleer TM
Detailed Description:
This is a randomized placebo-controlled study in subjects with Pulmonary Arterial Hypertension PAH with an NYHA Class of III or IV who are receiving conventional therapy and bosentan Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug active or placebo at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan At the end of the double-blind phase study open label Iloprost will be provided
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Cotherix | None | None | None |
| STEP | None | None | None |
| Pulmonary Hypertension | None | None | None |
| Pulmonary Artery | None | None | None |