Expired Study
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Gainesville, Florida 32610


Purpose:

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.


Study summary:

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.


Criteria:

Prerandomization Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00093912


Primary Contact:

Study Director
Malcolm Lloyd, MD
The Medicines Company - Medical Director, Clinical Operations


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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