Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

Phase 3 Completed 20 enrolled Rigshospitalet, Denmark

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.

Timeline

Start: 2006-03
Primary completion: 2008-01
Completion: 2008-01

Outcome

Missed primary endpoint

paper Adding sildenafil to bosentan did not improve the 6 MWD significantly (21 vs. 8 m, P = 0.48) PMID 20202971 ↗

Publications

Iversen K, Jensen AS, Jensen TV, Vejlstrup NG, Sondergaard L. Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2010 May;31(9):1124-31. doi: 10.1093/eurheartj/ehq011. Epub 2010 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	—	—
Subject	Sildenafil	Unknown	50 mg	—