NCT00093912

Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

• 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 perioperative hypertension. Approximately 250-500 patients with perioperative 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 sodium nitroprusside.

Detailed description

The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and sodium nitroprusside 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	sodium nitroprusside

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-10-01
• Completion: 2006-11-01
• First posted: 2004-10-08
• Last updated: 2014-05-06

Locations

29 sites across 1 country: United States