Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan

NCT01051960 ↗

Phase 4 Completed 12 enrolled University of California, Los Angeles Gilead Sciences · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma

Timeline

Start: 2009-03
Primary completion: 2010-06
Completion: 2011-01

Outcome

Met primary endpoint

paper At 24 weeks there were improvements in mean exercise PVR (85.8 dynes × second/cm(5) ; P = 0.003) PMID 22777623 ↗

Publications

Results Saggar R, Khanna D, Shapiro S, Furst DE, Maranian P, Clements P, Abtin F, Dua S, Belperio J, Saggar R. Brief report: effect of ambrisentan treatment on exercise-induced pulmonary hypertension in systemic sclerosis: a prospective single-center, open-label pilot study. Arthritis Rheum. 2012 Dec;64(12):4072-7. doi: 10.1002/art.34614.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ambrisentan	Small molecule	5 mg	Oral
Subject	Ambrisentan	Small molecule	10 mg	Oral