Clinical trial NCT00369837: Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
Official title: Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Study drug initiation through the first 3 minutes of the infusion
measure: Percentage of patients who reach the prespecified target SBP range
timeFrame: Within 30 minutes of the initiation of the infusion
Secondary outcomes:
measure: Time to attainment of the 30-minute SBP target range
timeFrame: During the 30-minute period from initiation of infusion
measure: Change in heart rate
timeFrame: During the 30-minute period from initiation of infusion
measure: Mean and median dose of clevidipine during the treatment period
timeFrame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours)
measure: Proportion of patients transitioning to oral antihypertensive therapy
timeFrame: Within 6 hours of stopping study drug infusion
measure: Safety of clevidipine infusion for 18 hours or longer
timeFrame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours)
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Jackson Hospital
state: Alabama
city: Los Angeles
country: United States
facility: VA Medical Center W. LA
state: California
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: New Orleans
country: United States
facility: Louisiana State University Medical Center/Charity Hospital
state: Louisiana
city: Shreveport
country: United States
facility: Critical Care Research Center at Louisiana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Good Samaritan Hospital
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center
state: Oregon
city: Erie
country: United States
facility: Hamot Shock Trauma
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Pennsylvania Hospital
name: Charles V Pollack, MA MD FACEP
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Frank Peacock, MD FACEP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.