Overview

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

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Medicines Company
Treatments:
Clevidipine
Nicardipine
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