Hypertension
Conditions
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.
Interventions
DRUGclevidipine
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..
Sponsors
The Medicines Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Study drug initiation through the first 3 minutes of the infusion |
| Percentage of patients who reach the prespecified target SBP range | Within 30 minutes of the initiation of the infusion |
Secondary
| Measure | Time frame |
|---|---|
| Mean and median dose of clevidipine during the treatment period | Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours) |
| Time to attainment of the 30-minute SBP target range | During the 30-minute period from initiation of infusion |
| Safety of clevidipine infusion for 18 hours or longer | 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 | Within 6 hours of stopping study drug infusion |
| Change in heart rate | During the 30-minute period from initiation of infusion |
Countries
United States
Outcome results
None listed