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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Antihypertensive Agents; Clevidipine

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