A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

Phase 2 Completed 200 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.

Timeline

Start: 2006-03-27
Primary completion: 2008-05-01
Completion: 2008-05-01

Outcome

Met primary endpoint

paper Subjects treated with sitaxsentan had an increase in median treadmill time (90 s) compared with placebo-treated subjects (37 s, p = 0.0302). PMID 24720918 ↗

registry analysis (unspecified test); Sitaxsentan vs Placebo; p = 0.0302; Median Difference (Net) 43.0; ANCOVA NCT00303498 ↗

Publications

Zile MR, Bourge RC, Redfield MM, Zhou D, Baicu CF, Little WC. Randomized, double-blind, placebo-controlled study of sitaxsentan to improve impaired exercise tolerance in patients with heart failure and a preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):123-30. doi: 10.1016/j.jchf.2013.12.002. Epub 2014 Feb 26.

Drugs

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