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

• ClinicalTrials.gov Identifier: NCT00369837
• Recruitment Status: Completed
• First Posted: August 29, 2006
• Last Update Posted: May 22, 2014
• Sponsor: The Medicines Company
• Information provided by (Responsible Party): The Medicines Company

Tracking Information

• First Submitted Date: August 25, 2006
• First Posted Date: August 29, 2006
• Last Update Posted Date: May 22, 2014
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 21, 2014)

• 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) [ Time Frame: Study drug initiation through the first 3 minutes of the infusion ]
• Percentage of patients who reach the prespecified target SBP range [ Time Frame: Within 30 minutes of the initiation of the infusion ]

Original Primary Outcome Measures (submitted: August 25, 2006)

• 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

Current Secondary Outcome Measures (submitted: May 21, 2014)

• Time to attainment of the 30-minute SBP target range [ Time Frame: During the 30-minute period from initiation of infusion ]
• Change in heart rate [ Time Frame: During the 30-minute period from initiation of infusion ]
• Mean and median dose of clevidipine during the treatment period [ Time Frame: 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 [ Time Frame: Within 6 hours of stopping study drug infusion ]
• Safety of clevidipine infusion for 18 hours or longer [ Time Frame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours) ]

Original Secondary Outcome Measures (submitted: August 25, 2006)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

Drug: clevidipine

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..

Other Name: clevidipine, Cleviprex

Study Arms

Experimental: clevidipine

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.

Intervention: Drug: clevidipine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 21, 2014): 131
• Original Enrollment (submitted: August 25, 2006): 100
• Actual Study Completion Date: February 2007
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00369837
• Other Study ID Numbers: TMC-CLV-06-02; VELOCITY ( Other Identifier: Sponsor )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Medicines Company
• Original Responsible Party: Not Provided
• Current Study Sponsor: The Medicines Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Charles V Pollack, MA MD FACEP; Pennsylvania Hospital
• Principal Investigator: Frank Peacock, MD FACEP; The Cleveland Clinic

• PRS Account: The Medicines Company
• Verification Date: May 2014