Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093262
First received: October 5, 2004
Last updated: October 29, 2008
Last verified: October 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

Resource links provided by NLM:


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
Huntington Memorial Hospital
Pasadena, California, United States, 91109
Stanford University School of Medicine
Stanford, California, United States, 94305-5640
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Heart Care Research Foundation
Blue Island, Illinois, United States, 60406
MacNeal Hospital
Glencoe, Illinois, United States, 60022
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

Publications:
ClinicalTrials.gov Identifier: NCT00093262     History of Changes
Other Study ID Numbers: TMC-CLV-03-02, ESCAPE-2
Study First Received: October 5, 2004
Last Updated: October 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Post-operative Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014