Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00578786
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2007-12-19
Brief Title:
A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 NCT00423748 or AMB-321 NCT00423202
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 NCT00423748 or AMB-321 NCT00423202
Status:
COMPLETED
Status Verified Date:
2013-01
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:
AMB-320321-E was designed to provide long-term controlled monitoring of pulmonary arterial hypertension PAH patients treated with ambrisentan AMB in order to properly define the adverse event profile associated with this endothelin receptor antagonist ERA including the incidence and severity of elevated serum liver function tests LFTs In addition this study continued the efficacy assessments of the previous studies examined long-term AMB treatment success and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH
Detailed Description:
AMB-320 ARIES-1 NCT00423748 and AMB-321 ARIES-2 NCT00423202 were 12-week Phase 3 randomized double-blind placebo-controlled multicenter efficacy studies of AMB in subjects with PAH The objectives of these studies were to determine the effect of three doses of AMB 25 50 and 100 mg on exercise capacity as well as several clinical measures of PAH The current study NCT00578786 was unblinded by design prior to completion The ARIES studies were identical except for the dose groups assessed and the geographic locations where the studies were conducted Both studies evaluated placebo and 50-mg AMB dose groups however AMB-320 NCT00423748 also examined an AMB dose of 100 mg while AMB-321 NCT00423202 included an AMB dose of 25 mg AMB-320321-E was an optional study for subjects who had participated in AMB-320 NCT00423748 or AMB-321 NCT00423202 that allowed continued long-term treatment with AMB
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-E | None | None | None |