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| ID | Type | Description | Link |
|---|---|---|---|
| VELOCITY | Other Identifier | Sponsor |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to attainment of the 30-minute SBP target range | During the 30-minute period from initiation of infusion | |
| Change in heart rate | During the 30-minute period from initiation of infusion | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles V Pollack, MA MD FACEP | Pennsylvania Hospital | Principal Investigator |
| Frank Peacock, MD FACEP | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Hospital | Montgomery | Alabama | 36106 | United States | ||
| VA Medical Center W. LA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18534716 | Result | 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. |
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|
|
| 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) |
| Proportion of patients transitioning to oral antihypertensive therapy | Within 6 hours of stopping study drug 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) |
| Los Angeles |
| California |
| 90073 |
| United States |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Louisiana State University Medical Center/Charity Hospital | New Orleans | Louisiana | 70118 | United States |
| Critical Care Research Center at Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Good Samaritan Hospital | Baltimore | Maryland | 21239 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Providence Heart & Vascular Institute, d/b/a Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Hamot Shock Trauma | Erie | Pennsylvania | 16550 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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