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Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: clevidipine (Drug); nicardipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Malcolm Lloyd, MD, Study Director, Affiliation: The Medicines Company - Medical Director, Clinical Operations

Summary

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after 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 nicardipine.

Clinical Details

Official title: Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of death, stroke, MI, and renal dysfunction

Detailed description: The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 nicardipine

- 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:

- Expected to survive beyond 24 hours post-surgical procedure

- No surgical complications or conditions, present or anticipated, that preclude them

from inclusion in the study

- Determined to be hypertensive postoperatively as determined by the investigator

Locations and Contacts

Mobile Infirmary Medical Center, Mobile, Alabama 36607, United States

Wesley Medical Center, Wichita, Kansas 67214, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Touro Infirmary, New Orleans, Louisiana 70115, United States

Jack D. Weller Hospital, Bronx, New York 10461, United States

Montefiore Medical Center, Bronx, New York 10467, United States

Columbia University - College of Physicians and Surgeons, New York, New York 10032, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

VA Medical Center McGuire, Richmond, Virginia 23249, United States

Additional Information

Starting date: May 2004
Last updated: May 5, 2014

Page last updated: August 23, 2015

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