Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Last updated: May 5, 2014
Sponsor: The Medicines Company
Overall Status: Completed

Phase

3

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT00093925
TMC-CLV-03-05
ECLIPSE-NIC
  • Ages > 18
  • All Genders

Study 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 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 nicardipine.

Eligibility Criteria

Inclusion

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 ArteryBypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery,and/or valve replacement/repair surgery

Exclusion

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 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 placea patient at undue risk by being enrolled in the trial

  • Participation in another therapeutic drug or therapeutic device trial within 30 daysof starting study Postrandomization Inclusion Criteria:

  • Expected to survive beyond 24 hours post-surgical procedure

  • No surgical complications or conditions, present or anticipated, that preclude themfrom inclusion in the study

  • Determined to be hypertensive postoperatively as determined by the investigator

Study Design

Total Participants: 739
Study Start date:
May 01, 2004
Estimated Completion Date:
September 30, 2006

Study 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 the clevidipine and nicardipine 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.

Connect with a study center

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36607
    United States

    Site Not Available

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Touro Infirmary

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Jack D. Weller Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University - College of Physicians and Surgeons

    New York, New York 10032
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • VA Medical Center McGuire

    Richmond, Virginia 23249
    United States

    Site Not Available

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