Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Phase 4 Completed 105 enrolled Viatris Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

Timeline

Start: 2006-09
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

paper week-12 6MWD increases were similar (least squares mean difference [sildenafil-placebo], -2.4 m [90% CI: -21.8 to 17.1 m]; P = 0.6); PMID 28874133 ↗

paper Sildenafil, in addition to stable (≥3 months) bosentan therapy, had no benefit over placebo for 12-week change from baseline in 6MWD. PMID 28874133 ↗

Publications

Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	20 mg	Oral
Background	Bosentan	Other / unclassified	62.5 mg	—
Background	Bosentan	Other / unclassified	125 mg	—