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

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00369837

Run by

The Medicines Company

People needed

131

Starts

2006-09-01

Expected to finish

2007-02-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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