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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093925

Acronym

ECLIPSE-NIC

Enrollment

739

Registered

2004-10-08

Start date

2004-05-31

Completion date

2006-09-30

Last updated

2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Postoperative hypertension

Brief 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.

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.

Interventions

DRUGclevidipine

DRUGnicardipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence of death, stroke, MI, and renal dysfunction	Initiation of study drug infusion through post-operative Day 30

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026