Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091598
Status:
COMPLETED
Last Update Posted:
2010-03-08
First Post:
2004-09-10
Brief Title:
ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension PAH
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
ARIES 1 and ARIES 2 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:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH
Detailed Description:
ARIES-1 in North America and Australia
ARIES-2 in Western and Eastern Europe South America and Israel
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
ARIES-2 in Western and Eastern Europe South America and Israel
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