Clevidipine in the Perioperative Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093912
First received: October 7, 2004
Last updated: October 29, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension.


Condition Intervention Phase
Hypertension
Drug: Clevidipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Estimated Enrollment: 500
Study Start Date: October 2004
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093912

  Hide Study Locations
Locations
United States, Alabama
Saint Vincents Hospital
Birmingham, Alabama, United States, 35205
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
United States, California
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
National Institute of Clinical Research
Los Angeles, California, United States, 90017
Huntington Memorial Hospital
Pasadena, California, United States, 91109
University of California
San Francisco, California, United States, 94143-0648
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Regional Medical Center - Bayonet Point
Hudson, Florida, United States, 34667
Sacred Heart Health System
Pensacola, Florida, United States, 32504
United States, Hawaii
Kaiser Permanente
Honolulu, Hawaii, United States, 96817
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Touro Infirmary
New Orleans, Louisiana, United States, 70115
United States, Minnesota
Saint Lukes Hospital
Duluth, Minnesota, United States, 55805
United States, Montana
International Heart Institute
Missoula, Montana, United States, 59802
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mt. Sinai Medical Center
New York, New York, United States, 10029-6574
New York University Medical Center
New York, New York, United States, 10016
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030-4211
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84112
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin VAMC - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00093912     History of Changes
Other Study ID Numbers: TMC-CLV-03-04, ECLIPSE-SNP
Study First Received: October 7, 2004
Last Updated: October 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Perioperative Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nitroprusside
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 17, 2014