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Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY) (VELOCITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00369837
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Description
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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 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients with or without major organ injury, particularly with respect to controlled dose adjustment to desired effect and prolonged continuous infusion. Enrollment of patients into the study was to continue until the target goal of 100 patients with at least 18 hours of continuous clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ injury, was met.

Condition or disease Intervention/treatment Phase
Hypertension Drug: clevidipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
Study Start Date : September 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Clevidipine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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 Name: clevidipine, Cleviprex


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients in whom SBP falls below the lower limit of the patient-specific, pre-determined blood pressure target range at the initial dose (2.0 mg/h) [ Time Frame: Study drug initiation through the first 3 minutes of the infusion ]
  2. Percentage of patients who reach the prespecified target SBP range [ Time Frame: Within 30 minutes of the initiation of the infusion ]

Secondary Outcome Measures :
  1. Time to attainment of the 30-minute SBP target range [ Time Frame: During the 30-minute period from initiation of infusion ]
  2. Change in heart rate [ Time Frame: During the 30-minute period from initiation of infusion ]
  3. Mean and median dose of clevidipine during the treatment period [ Time Frame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours) ]
  4. Proportion of patients transitioning to oral antihypertensive therapy [ Time Frame: Within 6 hours of stopping study drug infusion ]
  5. Safety of clevidipine infusion for 18 hours or longer [ Time Frame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369837


Locations
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United States, Alabama
Jackson Hospital
Montgomery, Alabama, United States, 36106
United States, California
VA Medical Center W. LA
Los Angeles, California, United States, 90073
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Louisiana
Louisiana State University Medical Center/Charity Hospital
New Orleans, Louisiana, United States, 70118
Critical Care Research Center at Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oregon
Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hamot Shock Trauma
Erie, Pennsylvania, United States, 16550
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Medicines Company
Investigators
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Principal Investigator: Charles V Pollack, MA MD FACEP Pennsylvania Hospital
Principal Investigator: Frank Peacock, MD FACEP The Cleveland Clinic
More Information
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Publications of Results:

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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00369837    
Other Study ID Numbers: TMC-CLV-06-02
VELOCITY ( Other Identifier: Sponsor )
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Clevidipine
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs