NCT01042158 - A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions

Pulmonary Arterial HypertensionSystemic SclerosisScleroderma Spectrum of DiseasesConnective Tissue DiseasePulmonary Hypertension

Interventions

DRUG

tadalafil and ambrisentan upfront combination therapy

tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.

Trial Locations (1)

21287

Johns Hopkins University, Baltimore