Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
NCT ID: NCT00369837
Last Updated: 2014-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2006-09-30
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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clevidipine
A patient-specific blood pressure target range (TR) of ≥20 mm Hg and ≤40 mm Hg SBP was prespecified by the investigator. Once established, clevidipine (0.5 mg/mL in 20% lipid emulsion) intravenous infusion was initiated at 2.0 mg/h and maintained for the first 3 minutes. Clevidipine was up-titrated, as tolerated by the patient, by doubling the dose every 3 minutes until the prespecified systolic blood pressure (SBP) target range was achieved and could continue to be titrated up or down to maintain the desired long-term SBP reduction.
clevidipine
Clevidipine was required to be administered continuously for a minimum of 18 hours and a maximum of 96 hours and was not to exceed a rate of 32.0 mg/h at any time. Use of an additional or alternative intravenous antihypertensive agent was allowed if the blood pressure target range was not achieved or maintained. If transition to an oral antihypertensive agent is required, then approximately 1 hour prior to the anticipated cessation of clevidipine infusion, but no less than at the 18-hour time point, an oral antihypertensive agent was allowed to be administered as clevidipine was down-titrated or terminated as needed in order to achieve the desired blood pressure level..
Interventions
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clevidipine
Clevidipine was required to be administered continuously for a minimum of 18 hours and a maximum of 96 hours and was not to exceed a rate of 32.0 mg/h at any time. Use of an additional or alternative intravenous antihypertensive agent was allowed if the blood pressure target range was not achieved or maintained. If transition to an oral antihypertensive agent is required, then approximately 1 hour prior to the anticipated cessation of clevidipine infusion, but no less than at the 18-hour time point, an oral antihypertensive agent was allowed to be administered as clevidipine was down-titrated or terminated as needed in order to achieve the desired blood pressure level..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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Principal Investigators
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Charles V Pollack, MA MD FACEP
Role: PRINCIPAL_INVESTIGATOR
Pennsylvania Hospital
Frank Peacock, MD FACEP
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Jackson Hospital
Montgomery, Alabama, United States
VA Medical Center W. LA
Los Angeles, California, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, United States
Louisiana State University Medical Center/Charity Hospital
New Orleans, Louisiana, United States
Critical Care Research Center at Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Good Samaritan Hospital
Baltimore, Maryland, United States
Duke University Medical Center
Durham, North Carolina, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center
Portland, Oregon, United States
Hamot Shock Trauma
Erie, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center
Houston, Texas, United States
Countries
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References
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Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009 Mar;53(3):329-38. doi: 10.1016/j.annemergmed.2008.04.025. Epub 2008 Jun 5.
Other Identifiers
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VELOCITY
Identifier Type: OTHER
Identifier Source: secondary_id
TMC-CLV-06-02
Identifier Type: -
Identifier Source: org_study_id
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