NCT00093249

Brief Summary

The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2004

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

October 5, 2004

Last Update Submit

August 21, 2014

Conditions

Hypertension

Keywords

Pre-operative hypertension

Outcome Measures

Primary Outcomes (1)

  • Incidence of bailout during 30-minute treatment period

    discontinuation of study drug categorized according to the following reasons: * Bailout for lack of efficacy * Bailout for safety reason(s) * Bailout due to treatment failure

    During the first 30 minutes post study drug initiation

Secondary Outcomes (4)

  • Median time to target SBP lowering effect (defined as a reduction by 15% or more)

    During the first 30 minutes post study drug initiation

  • Mean arterial pressure (MAP) change from baseline

    During the first 30 minutes post study drug initiation

  • Heart rate change from baseline

    During the first 30 minutes post study drug initiation

  • Incidence of bailout by causality

    During the first 30 minutes post study drug initiation

Study Arms (2)

clevidipine

EXPERIMENTAL

Clevidipine was administered in a blinded fashion by intravenous (IV) infusion, starting at a rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr) and titrating upward, as tolerated, in doubling increments approximately every 90 seconds to achieve the desired blood pressure-lowering effect. Up-titration to 3.2 μg/kg/min (16 mg/hr) was allowed. Infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing in serial increments of 1.5 μg/kg/min up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.

Drug: clevidipine

placebo

PLACEBO COMPARATOR

Placebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.

Drug: placebo

Interventions

clevidipineDRUG

Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.

Also known as: clevidipine, Cleviprex
clevidipine
placeboDRUG

Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent before initiation of any study-related procedures.
  • Be at least 18 years of age
  • Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting \[CABG\], Off Pump Coronary Artery Bypass \[OPCAB\], Minimally Invasive Direct Coronary Artery Bypass \[MIDCAB\] surgery, and/or valve replacement/repair procedures)
  • Have a recent history (within 6 months of randomization) of hypertension requiring treatment with antihypertensive medication(s) or be actively hypertensive upon admission

You may not qualify if:

  • 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
  • Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
  • Pre-existing left bundle branch block or 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
  • After the insertion of an arterial line, the patient is determined to meet the per protocol preoperative definition of hypertension, i.e. systolic blood pressure (SBP) \> 160 mmHg
  • It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cardio-Thoracic Surgeons, PC

Birmingham, Alabama, 35213, United States

Location

St Vincent Medical Center

Los Angeles, California, 90057, United States

Location

Discovery Alliance - Hudson

Hudson, Florida, 34667, United States

Location

Discovery Alliance - Sacred Heart Hospital

Pensacola, Florida, 32503, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30322, United States

Location

MacNeal Hospital

Berwyn, Illinois, 60402, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital, The Linder Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Memorial Herman Memorial City Hospital

Houston, Texas, 77024, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Houston Northwest Medical Center

Houston, Texas, 77090, United States

Location

Swedish Hospital Medical Center

Seattle, Washington, 98104-1318, United States

Location

Related Publications (1)

  • Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Aronson S, Newman MF. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg. 2007 Oct;105(4):918-25, table of contents. doi: 10.1213/01.ane.0000281443.13712.b9.

    PMID: 17898366RESULT

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2004

First Posted

October 7, 2004

Study Start

January 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

US(12)