Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

Summary

This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.

Timeline

Start

2008-12

Primary completion

2011-03

Completion

2011-03

Outcome

Met 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 analysis (superiority or other test); Sitaxsentan vs Placebo; p = 0.0104; Mean Difference (Final Values) 14 (95% CI 3 to 26) NCT00795639 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitaxentan	Small molecule	100 mg	Oral

Indications