Status:
COMPLETED
Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to determine the safety of clevidipine for treating severely elevated blood pressure, defined as systolic (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>115 mmH...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>115 mmHg assessed on two successive occasions, 15 minutes apart at baseline
- Written informed consent
Exclusion
- SBP ≤180 mmHg and/or DBP ≤115 mmHg
- Expectation that the patient will not tolerate intravenous antihypertensive therapy for at least 18 hours
- Known or suspected aortic dissection
- Administration of an agent for treating hypertension within 2 hours of clevidipine administration
- Severe hypertension known to be precipitated by use of, or withdrawal from, alcohol or illicit drugs, or intentional overdose of illicit or prescription drugs
- Positive pregnancy test
- Intolerance to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Known liver failure or cirrhosis
- Participation in clinical research studies of other investigational drugs or devices within 30 days of enrollment
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00369837
Start Date
September 1 2006
End Date
February 1 2007
Last Update
May 22 2014
Active Locations (14)
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1
Jackson Hospital
Montgomery, Alabama, United States, 36106
2
VA Medical Center W. LA
Los Angeles, California, United States, 90073
3
The George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
4
Louisiana State University Medical Center/Charity Hospital
New Orleans, Louisiana, United States, 70118