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

Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: clevidipine

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
      • Jackson Hospital
  • California
    • Los Angeles, California, United States, 90073
      • VA Medical Center W. LA
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Louisiana State University Medical Center/Charity Hospital
    • Shreveport, Louisiana, United States, 71103
      • Critical Care Research Center at Louisiana State University Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Good Samaritan Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16550
      • Hamot Shock Trauma
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: clevidipine, Cleviprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Study drug initiation through the first 3 minutes of the infusion
Percentage of patients who reach the prespecified target SBP range	Within 30 minutes of the initiation of the infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Principal Investigator: Charles V Pollack, MA MD FACEP, Pennsylvania Hospital; Principal Investigator: Frank Peacock, MD FACEP, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: August 25, 2006
• First Submitted That Met QC Criteria: August 25, 2006
• First Posted (Estimate): August 29, 2006

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: TMC-CLV-06-02; Velocity (Sponsor)