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

Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: clevidipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Charles V Pollack, MA MD FACEP, Principal Investigator, Affiliation: Pennsylvania Hospital
Frank Peacock, MD FACEP, Principal Investigator, Affiliation: The Cleveland Clinic


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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)

Percentage of patients who reach the prespecified target SBP range

Secondary outcome:

Time to attainment of the 30-minute SBP target range

Change in heart rate

Mean and median dose of clevidipine during the treatment period

Proportion of patients transitioning to oral antihypertensive therapy

Safety of clevidipine infusion for 18 hours or longer


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Jackson Hospital, Montgomery, Alabama 36106, United States

VA Medical Center W. LA, Los Angeles, California 90073, United States

The George Washington University Medical Center, Washington, District of Columbia 20037, United States

Louisiana State University Medical Center/Charity Hospital, New Orleans, Louisiana 70118, United States

Critical Care Research Center at Louisiana State University Health Sciences Center, Shreveport, Louisiana 71103, United States

Good Samaritan Hospital, Baltimore, Maryland 21239, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Metrohealth Medical Center, Cleveland, Ohio 44109, United States

The Cleveland Clinic, Cleveland, Ohio 44195, United States

The Toledo Hospital, Toledo, Ohio 43606, United States

Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center, Portland, Oregon 97225, United States

Hamot Shock Trauma, Erie, Pennsylvania 16550, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States

The University of Texas Health Science Center, Houston, Texas 77030, United States

Additional Information

Starting date: September 2006
Last updated: May 21, 2014

Page last updated: August 20, 2015

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