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Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)

Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: clevidipine (Drug); nitroglycerin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Malcolm Lloyd, MD, Study Director, Affiliation: The Medicines Company - Medical Director, Clinical Operations


The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 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 nitroglycerin.

Clinical Details

Official title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of death, stroke, MI and renal dysfunction

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 the clevidipine and nitroglycerin 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 nitroglycerin

- 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

Locations and Contacts

Baptist Medical Center, Montclair, Birmingham, Alabama 35213, United States

Brookwood Medical Center, Birmingham, Alabama 35209, United States

Medical Center East, Birmingham, Alabama 35235, United States

Baptist Medical Center, South, Montgomery, Alabama 36116, United States

University Medical Center, Tucson, Arizona 85724, United States

Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States

Keck School of Medicine, University of Southern California, Los Angeles, California 90033, United States

Huntington Memorial Hospital, Pasadena, California 91109, United States

University of California, San Francisco, California 94143-0648, United States

Regional Medical Center - Bayonet Point, Hudson, Florida 34667, United States

Health First Holmes Regional Medical Center, Melbourne, Florida 32901, United States

Sacred Heart Health System, Pensacola, Florida 32504, United States

Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii 96817, United States

Saint Francis Hospital, Evanston, Illinois 60202, United States

Wesley Medical Center, Wichita, Kansas 67214, United States

St Joseph Medical Center, Towson, Maryland 21204, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

New York University Medical Center, New York, New York 10016, United States

Sterling Research Group, Ltd., Cincinnati, Ohio 45219, United States

The Christ Hospital, The Linder Clinical Trial Center, Cincinnati, Ohio 45219, United States

Portland VA Medical Center, Portland, Oregon 97239, United States

Houston Northwest Medical Center, Houston, Texas 77090, United States

Memorial Herman Memorial City Hospital, Houston, Texas 77024, United States

Michael E DeBakey VA Medical Center, Houston, Texas 77030-4211, United States

The Methodist Hospital, Houston, Texas 77030, United States

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States

Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States

Saint Joseph Medical Center, Tacoma, Washington 98405, United States

Additional Information

Starting date: April 2004
Last updated: May 5, 2014

Page last updated: August 23, 2015

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