Status:
COMPLETED
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
Lead Sponsor:
Gilead Sciences
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
16-75 years
Phase:
PHASE4
Brief Summary
To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (P...
Detailed Description
The primary objective of this study is to evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to backgroun...
Eligibility Criteria
Inclusion
- Selected Inclusion Criteria
- Must be between 16 and 75 years of age;
- Must weigh at least 40 kg;
- Have a current diagnosis of idiopathic PAH, familial PAH, or PAH that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or human immunodeficiency virus (HIV);
- Have WHO functional class III symptoms;
- Be receiving sildenafil or tadalafil monotherapy for the treatment of PAH for at least the past 12 weeks and at a stable dose for at least 8 consecutive weeks;
- Meet all of the following hemodynamic criteria by means of a right heart catheterization: mPAP of at least 25 mmHg; PVR of at least 400 dyne\*sec/cm5; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of not more than 15 mmHg;
- Meet all of the following pulmonary function test criteria no more than 12 weeks before the screening visit: total lung capacity at least 60% of predicted normal and forced expiratory volume in 1 second of at least 65% of predicted normal;
- Able to walk at least 150 meters during the screening 6-minute walk test (6MWT);
- If receiving calcium channel blockers or 5-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (i.e., statins) must be on stable therapy for at least 4 weeks;
- If diagnosed with HIV, must have stable disease status.
- Selected Exclusion Criteria:
- Have a current pulmonary hypertension diagnosis other than idiopathic PAH, familial PAH, or PAH that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or HIV;
- Have left ventricular ejection fraction (LVEF) ≤40% or clinically significant ischemic, valvular, or constrictive heart disease;
- Have received chronic prostanoid or endothelin receptor antagonist (ERA) therapy (eg, bosentan, sitaxsentan) within the past 12 weeks;
- Have discontinued ERA treatment for any adverse reaction other than those associated with liver function test abnormalities;
- Have received IV inotropes within 2 weeks;
- Have a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is greater than 2.0x the upper limit of normal.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00617305
Start Date
April 1 2008
End Date
July 1 2011
Last Update
July 30 2012
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Alabama
Mobile, Alabama, United States, 36617
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85013
3
West Los Angeles Healthcare Center
Los Angeles, California, United States, 90073
4
Harbor - UCLA
Torrance, California, United States, 90502