At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
Ambrisentandrug
Likely dose
Ambrisentan oral tablets once dailyAI-extracted
Key inclusion· 5
- ✓Age 18 years or older
- ✓Confirmed diagnosis of pulmonary hypertension from eligible etiologies: PAH (idiopathic, familial, or associated with collagen vascular disease, congenital shunts, HIV, drugs/toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, splenectomy); PH associated with lung disease (COPD, ILD, sleep-disordered breathing, alveolar hypoventilation); chronic thromboembolic PH; or sarcoidosis-associated PH
- ✓Stable regimen for ≥4 weeks of background PH therapy (prostanoid, PDE-5 inhibitor, calcium channel blocker, or HMG-CoA reductase inhibitor)
- ✓Right heart catheterization completed prior to screening with hemodynamic criteria met (mPAP ≥25 mm Hg, PVR >3 mm Hg/L/min, PCWP or LVEDP <15 mm Hg)
Key exclusion· 6
- ✕Prior ambrisentan use in a clinical study
- ✕Bosentan or sitaxsentan use within 4 weeks before screening
- ✕AST or ALT >3× upper limit of normal at screening
- ✕Contraindication to endothelin receptor antagonist therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
In Brief
A Phase 3 clinical trial evaluating Ambrisentan for Pulmonary Hypertension. Completed, enrolled 224 participants across 39 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedSep 2006
Primary CompletionJul 2008
Study CompletionMay 2009
TodayJul 2026
First PostedSep 25, 2006
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.8 years ago
Interventions
Ambrisentandrug
Oral tablets taken once daily.