A RANDOMIZED, MULTICENTER STUDY OF FIRST-LINE AMBRISENTAN AND TADALAFIL COMBINATION THERAPY IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PROTOCOL NUMBER: GS-US-300-0140

AMBITION

Approval Date: 3/13/2012

Principal Investigator: Samuel Allen, DO

Objective: Primary objective is to compare the two treatment strategies: first line combination therapy: ambrisentan AND tadalafil)  VS first line monatherapy: ambrisentan OR tadalafil in subjects with PAH.   Safety and tolerability will also be compared.

This study is to test how well the drugs ambrisentan and tadalafil work together to treat Pulmonary Arterial Hypertension [PAH] (a narrowing of the arteries connecting the lungs to the heart that leads to an increase in blood pressure) compared to ambrisentan or tadalafil alone. We want to find out what effects, good or bad, they have on people with PAH. We also want to see how safe these drugs are when used together. These drugs have been approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of PAH. However, the combination of ambrisentan and tadalafil has not been previously studied and approved by the FDA.

Eligibility:

For more information visit

http://clinicaltrials.gov/ct2/show/NCT01178073

Contact Person:
Coleen Tessmar, Research Coordinator
248-964-8524

Status of Clinical Trial:
open and enrolling