drugset / Trial / NCT00093262

Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

NCT00093262 ↗

Phase 3 Completed 206 enrolled The Medicines Company
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.

Timeline

Start
2003-12
Primary completion
2004-10
Completion
2004-10

Outcome

Met primary endpoint

paper Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. PMID 18635468 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevidipine Small molecule 8 ug/kg Intravenous

Indications