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

The Medicines Company

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: clevidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369837

TMC-CLV-06-02

VELOCITY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

clevidipine

Experimental group

Description:

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.

Treatment:

Drug: clevidipine