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