Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380068
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2006-09-21
Brief Title:
Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
ARIES-3 A Phase 3 Long-Term Open-Label Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2012-04
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:
None
Brief Summary:
The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension PH Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension PAH long-term treatment success and survival
Detailed Description:
This study was to enroll up to 200 participants with PH due to the following etiologies 1 PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease congenital systemic-to-pulmonary shunts including Eisenmengers syndrome human immunodeficiency virus HIV infection drugs and toxins thyroid disorders glycogen storage disease Gaucher disease hemoglobinopathies and splenectomy WHO Group 1 2 PH associated with lung diseases andor hypoxemia including chronic obstructive pulmonary disease COPD interstitial lung disease ILD sleep-disordered breathing and alveolar hypoventilation disorders WHO Group 3 3 PH due to proximal or distal chronic thromboembolic obstruction WHO Group 4 and 4 PH due to sarcoidosis WHO Group 5 Participants with left heart disease or left heart failure were excluded WHO Group 2 Participants could be receiving prostacyclin or sildenafil therapy at baseline and participants who previously discontinued either bosentan sitaxsentan or both due to liver function test abnormalities were eligible
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-3 | None | None | None |