Status:
COMPLETED
Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)
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 postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coro...
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 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 nicardipine
- 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:
- Expected to survive beyond 24 hours post-surgical procedure
- No surgical complications or conditions, present or anticipated, that preclude them from inclusion in the study
- Determined to be hypertensive postoperatively as determined by the investigator
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
739 Patients enrolled
Trial Details
Trial ID
NCT00093925
Start Date
May 1 2004
End Date
September 1 2006
Last Update
May 6 2014
Active Locations (9)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
2
Wesley Medical Center
Wichita, Kansas, United States, 67214
3
Touro Infirmary
New Orleans, Louisiana, United States, 70115
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121