drugset / Trial / NCT01200732

Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome

NCT01200732

Phase 2 Completed 28 enrolled Govind Ballabh Pant Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp), systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this placebo controlled trial was to assess the effect of the drug on exercise capacity and functional class compared to placebo.

Timeline

Start
2008-02
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tadalafil Small molecule 40 mg Oral

Indications