Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

Summary

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Timeline

Start

2009-05

Primary completion

2011-03

Completion

2011-03

Outcome

Missed primary endpoint

Stopped: “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.”

registry Sitaxsentan and Placebo vs Sitaxsentan and Sildenafil; p = 0.5416; Cox Proportional Hazard 0.8616 (95% CI 0.602 to 1.233) NCT00796666 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	20 mg	Oral
Background	Sitaxentan	Small molecule	100 mg	Oral

Indications