NCT00093925

Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after 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 nicardipine.

Detailed description

The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	clevidipine
DRUG	nicardipine

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-07-01
• Completion: 2006-09-01
• First posted: 2004-10-08
• Last updated: 2014-05-06

Locations

9 sites across 1 country: United States