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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00799604 |
The purpose of this study is to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.
Condition | Intervention | Phase |
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Hypertension |
Drug: Clevidipine butyrate injectable emulsion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | An Open-label Study in Patients Undergoing Cardiac Surgery to Evaluate the Effect of Bolus Clevidipine Administration (SPRINT) |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
This open-label, single-arm study is designed to demonstrate the efficacy and safety of a bolus dose of clevidipine, a vascular-selective L-type calcium channel antagonist, in the management of hypertension in patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass.
Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. Prior to administration of study drug, a clinical examination will be carried out. For the purposes of this study, hypertension will be defined as systolic blood pressure ≥140 mm Hg immediately prior to initiation of study drug.
The study will occur in four separate periods: Screening period (-14 to -1 days), Treatment Period 1 (Day 1; before anesthesia to at least 15 minutes and up to 30 minutes after Bolus 1), Treatment Period 2 (Day 1; from the end of Treatment Period 1, after initiation of anesthesia to final bolus) and a Follow-up Period (up to 24 hours after final bolus), representing a maximum of 16 days on study.
It is planned that 10 patients will be allocated to each of the following 3 planned dose cohorts:
If the initial 5 patients dosed in a cohort demonstrate no response in SBP (≤5-10 mm Hg change in SBP) patients will be enrolled into the next higher dose cohort. If ≥1 of the initial patients in a cohort demonstrates a response in SBP, the full 10 patients will be enrolled. When at least 5 patients are enrolled in a cohort, dose escalation will be terminated if ≥60% of patients, demonstrate a SBP of ≤85 mm Hg (pre-anesthesia).
Clevidipine will be administered prior to induction of general anesthesia in Treatment Period 1 as an intravenous bolus (<5 seconds) by rapid injection directly into a peripheral venous catheter followed by a normal saline flush (10 mL). At the discretion of the Investigator, a second bolus dose of clevidipine (Bolus 2) may be administered in Treatment Period 2, after induction of general anesthesia at either 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
An additional dose cohort of up to 10 patients may be added if required (Cohort 4) in which clevidipine will be administered at a dose between 125 μg and 500 μg. The final determination of the dose to be used in Cohort 4 will be based on the results of Cohorts 1, 2 and 3.
Assessment of safety will be performed throughout the treatment period and for at least 6 hours after termination of study drug. Patients will be followed for up to 24 hours after the final bolus dose.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Manyak | 973-290-6163 | Christine.Manyak@THEMEDCO.com |
Contact: Leisa Waynick | 973-290-6082 | Leisa.Waynick@themedco.com |
United States, Massachusetts | |
Massachusetts General Hospital, Harvard Medical School | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Edwin G Avery, IV, MD 617-726-8980 EAVERY@PARTNERS.ORG | |
Contact: Anne Donnelly, RN 617-726-4159 ADONNELLY2@PARTNERS.ORG | |
Principal Investigator: Edwin G Avery, IV, MD | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Albert T. Cheung, MD 215-662-3785 cheungA@uphs.upenn.edu | |
Principal Investigator: Albert T. Cheung, MD |
Principal Investigator: | Albert T. Cheung, MD | University of Pennsylvania |
Principal Investigator: | Edwin G. Avery, IV, MD | Massachusetts General Hospital, Harvard Medical School |
Responsible Party: | The Medicines Company ( Linda Rootkin, Director of Clinical Operations ) |
Study ID Numbers: | TMC-CLV-08-02 |
Study First Received: | November 26, 2008 |
Last Updated: | July 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00799604 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypertension Antihypertensive Agent Calcium Channel Blocker |
Calcium, Dietary Vascular Diseases Calcium Channel Blockers |
Anesthetics Antihypertensive Agents Hypertension |
Vascular Diseases Cardiovascular Diseases Hypertension |