Status:
COMPLETED
Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 a...
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 t...
Eligibility Criteria
Inclusion
- Prerandomization
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age
- Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery
- Prerandomization
Exclusion
- Women of child-bearing potential (unless they have a negative pregnancy test)
- Recent cerebrovascular accident (within 3 months before randomization)
- Known intolerance to calcium channel blockers
- Known or suspected hypersensitivity to sodium nitroprusside
- Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
- Pre-existing permanent ventricular pacing
- Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
- Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
- Postrandomization Inclusion Criteria:
- Determined to be hypertensive perioperatively as determined by the investigator
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
739 Patients enrolled
Trial Details
Trial ID
NCT00093912
Start Date
June 1 2004
End Date
November 1 2006
Last Update
May 6 2014
Active Locations (29)
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1
Saint Vincents Hospital
Birmingham, Alabama, United States, 35205
2
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
3
Baptist Medical Center, Montclair
Birmingham, Alabama, United States, 35213
4
Baptist Medical Center, South
Montgomery, Alabama, United States, 36101