Status:
COMPLETED
Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
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 efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing co...
Detailed Description
The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment ...
Eligibility Criteria
Inclusion
- Pre-randomization
- Provide written informed consent before initiation of any study-related procedures.
- Be at least 18 years of age
- Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting \[CABG\], Off Pump Coronary Artery Bypass \[OPCAB\], Minimally Invasive Direct Coronary Artery Bypass \[MIDCAB\] surgery, and/or valve replacement/repair procedures)
- Pre-randomization
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
- Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
- Pre-existing left bundle branch block or 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
- Post-randomization 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 a double blind, placebo-controlled study
- Determined to be hypertensive (SBP \> 140 mm Hg) within 4 hours of arrival in a postoperative setting
- It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00093262
Start Date
December 1 2003
End Date
October 1 2004
Last Update
May 8 2014
Active Locations (15)
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1
Discovery Alliance - Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36602
2
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
3
Huntington Memorial Hospital
Pasadena, California, United States, 91109
4
Stanford University School of Medicine
Stanford, California, United States, 94305-5640