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

  Show 28 Study Locations
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