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

NCT00369837 | Completed Phase 3

• 2 other identifiers: TMC-CLV-06-02VELOCITY
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

Study Arms (1)

clevidipine

EXPERIMENTAL

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

Interventions

clevidipine DRUG

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..

Also known as: clevidipine, Cleviprex

clevidipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (14)

Jackson Hospital

Montgomery, Alabama, 36106, United States

Location

VA Medical Center W. LA

Los Angeles, California, 90073, United States

Location

The George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Louisiana State University Medical Center/Charity Hospital

New Orleans, Louisiana, 70118, United States

Location

Critical Care Research Center at Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Hamot Shock Trauma

Erie, Pennsylvania, 16550, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 18534716 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles V Pollack, MA MD FACEP

  Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

• Frank Peacock, MD FACEP

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2006
• First Posted: August 29, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (14)