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Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery

This study has been completed.

Sponsored by: The Medicines Company
Information provided by: The Medicines Company
ClinicalTrials.gov Identifier: NCT00093262
  Purpose

The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating postoperative hypertension.


Condition Intervention Phase
Hypertension
Drug: Clevidipine
Phase III

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Clevidipine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Incidence of bailout during 30-minute treatment period.

Secondary Outcome Measures:
  • During the 30-minute treatment period: time to SBP reduction by 15% or more; mean
  • arterial pressure change from baseline; heart rate change from baseline; incidence of bailout by causality.

Estimated Enrollment:   100
Study Start Date:   December 2003
Estimated Study Completion Date:   October 2004

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Pre-randomization Inclusion Criteria:

  • 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 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
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093262

Locations
United States, Alabama
Discovery Alliance - Mobile Infirmary Medical Center    
      Mobile, Alabama, United States, 36602
United States, California
Keck School of Medicine, University of Southern California    
      Los Angeles, California, United States, 90033
Stanford University School of Medicine    
      Stanford, California, United States, 94305-5640
Huntington Memorial Hospital    
      Pasadena, California, United States, 91109
United States, Georgia
Emory Hospital    
      Atlanta, Georgia, United States, 30322
United States, Illinois
MacNeal Hospital    
      Glencoe, Illinois, United States, 60022
Heart Care Research Foundation    
      Blue Island, Illinois, United States, 60406
United States, Kansas
Wesley Medical Center    
      Wichita, Kansas, United States, 67214
United States, Missouri
St. Lukes Hospital    
      Kansas City, Missouri, United States, 64111
United States, Montana
International Heart Institute    
      Missoula, Montana, United States, 59802
United States, New York
Mt. Sinai Medical Center    
      New York, New York, United States, 10029-6574
Columbia University - College of Physicians and Surgeons    
      New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center    
      Charlotte, North Carolina, United States, 28203
United States, Texas
Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion    
      Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin VAMC - Milwaukee    
      Milwaukee, Wisconsin, United States, 53295

Sponsors and Collaborators
The Medicines Company
  More Information


Study ID Numbers:   TMC-CLV-03-02, ESCAPE-2
First Received:   October 5, 2004
Last Updated:   August 3, 2006
ClinicalTrials.gov Identifier:   NCT00093262
Health Authority:   United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Post-operative Hypertension  

Study placed in the following topic categories:
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 09, 2008




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