Status:
COMPLETED
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II,...
Eligibility Criteria
Inclusion
- Must have completed Visit 14/Week 24 of the NCT00046319 study.
- Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for \>=4 weeks following their final study visit.
- Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria:
- Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.
- Must be stable on conventional therapy for PAH for \>=4 weeks prior to the Screening Visit.
Exclusion
- Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit.
- Intravenous inotrope use within 2 weeks prior to the Screening Visit.
- Females who are pregnant or breastfeeding.
- Contraindication to treatment with an endothelin receptor antagonist (ERA).
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00424021
Start Date
April 1 2003
End Date
December 1 2009
Last Update
January 27 2012
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