Clevidipine in the Postoperative Treatment of Hypertension - Full Text View

Sponsored by:	The Medicines Company
Information provided by:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00093925

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Clevidipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Clevidipine

Further study details as provided by The Medicines Company:

Estimated Enrollment:	500
Study Start Date:	October 2004
Estimated Study Completion Date:	July 2006

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093925

Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Touro Infirmary
New Orleans, Louisiana, United States, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Columbia University - College of Physicians and Surgeons
New York, New York, United States, 10032
Jack D. Weller Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
VA Medical Center McGuire
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

The Medicines Company

Investigators

Study Director:

Malcolm Lloyd, MD

The Medicines Company - Medical Director, Clinical Operations

More Information

Publications:

Study ID Numbers:	TMC-CLV-03-05, ECLIPSE-NIC
Study First Received:	October 7, 2004
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00093925 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Medicines Company:

Postoperative hypertension

Study placed in the following topic categories:

Vascular Diseases
Nicardipine
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on August 13, 2009