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Clevidipine in the Preoperative Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093886
First received: October 7, 2004
Last updated: October 29, 2008
Last verified: October 2008
History of Changes

October 7, 2004
October 29, 2008
October 2004
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Complete list of historical versions of study NCT00093886 on ClinicalTrials.gov Archive Site
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Clevidipine in the Preoperative Treatment of Hypertension
Evaluation of Clevidipine in the Preoperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)

The purpose of this study is to establish the safety of clevidipine in the treatment of preoperative hypertension.
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: Clevidipine
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Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
March 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00093886
TMC-CLV-03-03, ECLIPSE-NTG
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The Medicines Company
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Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
The Medicines Company
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP