Status:
COMPLETED
Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.
Detailed Description
Initiation of study drug infusion will commence with the occurrence of protocol-defined preoperative hypertension (SBP \> 160 mmHg) as measured via an indwelling arterial line. The study drug (clevid...
Eligibility Criteria
Inclusion
- Pre-randomization
- 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
- Pre-randomization
Exclusion
- 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
- Post-randomization Inclusion Criteria:
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00093249
Start Date
January 1 2004
End Date
November 1 2004
Last Update
August 22 2014
Active Locations (12)
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1
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, United States, 35213
2
St Vincent Medical Center
Los Angeles, California, United States, 90057
3
Discovery Alliance - Hudson
Hudson, Florida, United States, 34667
4
Discovery Alliance - Sacred Heart Hospital
Pensacola, Florida, United States, 32503