Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

Summary

This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.

Timeline

Start

2006-08-10

Primary completion

2008-03-31

Completion

2008-03-31

Outcome

Missed primary endpoint

registry Sitaxsentan (1 mg/kg) vs Placebo; p = 0.5307; Mean Difference (Net) -70.0 (95% CI -291.3 to 151.4); ANCOVA NCT00838383 ↗

registry Sitaxsentan (2 mg/kg) vs Placebo; p = 0.5121; Mean Difference (Net) -73.2 (95% CI -294.5 to 148.2); ANCOVA NCT00838383 ↗

registry Sitaxsentan (1 mg/kg) vs Placebo; p = 0.2735; Mean Difference (Net) -123.1 (95% CI -345.5 to 99.3); ANCOVA NCT00838383 ↗

registry Sitaxsentan (2 mg/kg) vs Placebo; p = 0.1223; Mean Difference (Net) -174.5 (95% CI -396.8 to 47.9); ANCOVA NCT00838383 ↗

registry Sitaxsentan (1 mg/kg) vs Placebo; p = 0.5505; Mean Difference (Net) -66.6 (95% CI -288.0 to 154.8); ANCOVA NCT00838383 ↗

registry Sitaxsentan (2 mg/kg) vs Placebo; p = 0.3237; Mean Difference (Net) -110.3 (95% CI -331.7 to 111.0); ANCOVA NCT00838383 ↗

registry Sitaxsentan (1 mg/kg) vs Placebo; p = 0.1412; Mean Difference (Net) -166.5 (95% CI -389.6 to 56.6); ANCOVA NCT00838383 ↗

registry Sitaxsentan (2 mg/kg) vs Placebo; p = 0.0813; Mean Difference (Net) -199.8 (95% CI -425.0 to 25.5); ANCOVA NCT00838383 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitaxentan	Small molecule	1 mg/kg	Intravenous
Subject	Sitaxentan	Small molecule	2 mg/kg	Intravenous

Indications

No indication recorded.