Clevidipine in the Perioperative Treatment of Hypertension

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

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

Condition Intervention Phase
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

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

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 identifier: NCT00093912

  Show 28 Study Locations
Sponsors and Collaborators
The Medicines Company
Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
  More Information

Publications: 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:
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on April 17, 2014