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Birmingham, Alabama 35205

  • Hypertension

Purpose:

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 250-500 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or sodium nitroprusside.


Study summary:

The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and sodium nitroprusside treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect and additional safety variables.


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


Study is Available At:


Original ID:

TMC-CLV-03-04


NCT ID:

NCT00093912


Secondary ID:

ECLIPSE-SNP


Study Acronym:

ECLISPE-SNP


Brief Title:

Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)


Official Title:

Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Medicines Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

739


Enrollment Type:

Actual


Overall Contact Information

Official Name:Malcolm Lloyd, MD
Study Director
The Medicines Company - Medical Director, Clinical Operations

Study Dates

Start Date:June 2004
Completion Date:November 2006
Completion Type:Actual
Primary Completion Date:October 2006
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:May 5, 2014
First Received Date:October 7, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence of death, stroke, MI and renal dysfunction
Time Frame:Initiation of study drug infusion through post-operative Day 30
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:clevidipine
Arm Name:clevidipine
Other Name:clevidipine, Cleviprex
Intervention Type:Drug
Name:sodium nitroprusside
Arm Name:sodium nitroprusside

Study Arms

Study Arm Type:Experimental
Arm Name:clevidipine
Description:Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above
Study Arm Type:Active Comparator
Arm Name:sodium nitroprusside
Description:Sodium nitroprusside (SNP) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The Medicines Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:18806012

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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