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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00369837
First received: August 25, 2006
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hypertension
Drug: clevidipine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients who reach the prespecified target SBP range [ Time Frame: Within 30 minutes of the initiation of the infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to attainment of the 30-minute SBP target range [ Time Frame: During the 30-minute period from initiation of infusion ] [ Designated as safety issue: No ]
  • Change in heart rate [ Time Frame: During the 30-minute period from initiation of infusion ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Proportion of patients transitioning to oral antihypertensive therapy [ Time Frame: Within 6 hours of stopping study drug infusion ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: September 2006
Study Completion Date: February 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369837

Locations
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
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
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
Principal Investigator: Charles V Pollack, MA MD FACEP Pennsylvania Hospital
Principal Investigator: Frank Peacock, MD FACEP The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00369837     History of Changes
Other Study ID Numbers: TMC-CLV-06-02, VELOCITY
Study First Received: August 25, 2006
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Clevidipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014