Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423748
Status:
COMPLETED
Last Update Posted:
2009-04-16
First Post:
2007-01-17
Brief Title:
Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Ambrisentan in PAH - A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2009-04
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:
A phase 3 randomized double-blind placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension
Detailed Description:
Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo Inclusion is not based on a specified WHO functional classification Rather subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded The study requires a historical cardiac catheterization and other diagnostic procedures
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 |
|---|---|---|---|
| ARIES-1 | None | None | None |