At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 610 enrolled
Drug / intervention
ambrisentan +1 moredrug
Likely dose
ambrisentan 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 3 clinical trial evaluating ambrisentan and tadalafil for Hypertension, Pulmonary. Completed, enrolled 610 participants across 143 sites in 14 countries.
Detailed Summary
The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom, United States
CollaboratorsGilead Sciences
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartOct 2010
Primary CompletionJul 2014
TodayJul 2026
First PostedAug 9, 2010
Enrollment StartOct 1, 2010
Primary CompletionJul 31, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.9 years ago
Interventions
ambrisentandrug
ambrisentan (target dose: 10mg)
tadalafildrug
tadalafil (target dose: 40mg)