Clinical Trials Directory

Trials / Completed

CompletedNCT01178073

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
610 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGambrisentanambrisentan (target dose: 10mg)
DRUGtadalafiltadalafil (target dose: 40mg)

Timeline

Start date
2010-10-01
Primary completion
2014-07-31
Completion
2014-07-31
First posted
2010-08-09
Last updated
2017-09-13
Results posted
2015-04-28

Locations

143 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT01178073. Inclusion in this directory is not an endorsement.