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Completed

NCT Number: NCT00369837

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jackson Hospital, Montgomery, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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..

Other names: clevidipine, Cleviprex

Primary outcomes

  1. 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

  2. Percentage of patients who reach the prespecified target SBP range

    Time frame: Within 30 minutes of the initiation of the infusion

Secondary outcomes

  1. Time to attainment of the 30-minute SBP target range

    Time frame: During the 30-minute period from initiation of infusion

  2. Change in heart rate

    Time frame: During the 30-minute period from initiation of infusion

  3. 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)

  4. Proportion of patients transitioning to oral antihypertensive therapy

    Time frame: Within 6 hours of stopping study drug infusion

  5. 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)

Sponsors and collaborators

Lead sponsor

The Medicines Company

Industry

Registry information

Official study title

Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

Acronym: VELOCITY

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2006
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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