Clevidipine in the Treatment of Patients With Severe Hypertension

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00369837
First received: August 25, 2006
Last updated: October 29, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to determine the safety of clevidipine for treating severely elevated blood pressure in patients with or without major organ injury, especially with respect to controlled dose adjustment to desired effect and continuous infusion.


Condition Intervention Phase
Hypertension
Drug: Clevidipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Percentage of patients in whom systolic blood pressure falls below the target range within 3 min of initiating clevidipine infusion;
  • Percentage of patients in whom systolic blood pressure reaches the target range within 30 min of initiating clevidipine infusion

Secondary Outcome Measures:
  • Time to attainment of 30-min blood pressure range;
  • Change in heart rate during the 30-min period from initiation of infusion;
  • Mean and median dose of clevidipine during the treatment period;
  • Proportion of patients transitioning to oral antihypertensive therapy within 6 hours of stopping infusion;
  • Safety of clevidipine infusion for 18 hours or longer

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369837

Locations
United States, Alabama
Jackson Hospital
Montgomery, Alabama, United States, 36106
United States, California
VA Medical Center W. LA
Los Angeles, California, United States, 90073
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Louisiana
Louisiana State University Medical Center/Charity Hospital
New Orleans, Louisiana, United States, 70118
Critical Care Research Center at Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
The Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oregon
Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hamot Shock Trauma
Erie, Pennsylvania, United States, 16550
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Charles V Pollack, MA MD FACEP Pennsylvania Hospital
Principal Investigator: Frank Peacock, MD FACEP The Cleveland Clinic
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00369837     History of Changes
Other Study ID Numbers: TMC-CLV-06-02
Study First Received: August 25, 2006
Last Updated: October 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014