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| Sponsor: | The Medicines Company |
|---|---|
| Information provided by (Responsible Party): | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00666328 |
Purpose
The purpose of this study is to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Hemorrhage |
Drug: Clevidipine butyrate injectable emulsion |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Evaluation of Patients With Acute Hypertension and Intracerebral Hemorrhage With Intravenous Clevidipine Treatment |
| Enrollment: | 37 |
| Study Start Date: | April 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Clevidipine butyrate injectable emulsion
Clevidipine butyrate injectable emulsion (0.5 mg/mL in 20% lipid emulsion; 100 mL bottles) will be administered intravenously to all patients via a single dedicated line. Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates can be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect is to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 96 hours. Patients will be followed for 7 days following termination of the clevidipine infusion. |
This is a multicenter, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly control acute hypertension in patients with intracerebral hemorrhage. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as SBP >160 mmHg immediately prior to initiation of study drug. Approximately 30 to 40 patients with acute ICH will be enrolled with approximately 10 patients requiring ICP monitoring. Infusion of study drug will be initiated within 12 hours of ICH symptom onset. All eligible patients will be enrolled to receive clevidipine in an open label manner. Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates can be attempted as needed to obtain the target SBP range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect is to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 96 hours. Twenty-four hour follow-up CT scan results will be recorded, including measurement of intracerebral hematoma volumes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug. Patients will be followed for 7 days following termination of the clevidipine infusion.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010-2975 | |
| United States, Hawaii | |
| The Queens Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Maryland | |
| The John Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Guilford Neurologic - Moses H Cone Health System | |
| Greensboro, North Carolina, United States, 27405 | |
| United States, Ohio | |
| Cleveland Clinic Hospitals | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Thomas jefferson University Stroke Research | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Main Medical Center | |
| Charleston, South Carolina, United States, 29425 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| The University Health Science Center at S.A. | |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| Germany | |
| Universitätsklinikum Leipzig | |
| Liebigstraße 22a, Leipzig, Germany, D-04103 | |
| Universitatsklinikum Erlangen | |
| Erlangen, Germany, D91054 | |
| Ruprech-Karls University | |
| Heidelberg, Germany, D69120 | |
| Principal Investigator: | Carmelo Graffagnino, MD | Duke University |
More Information
| Responsible Party: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00666328 History of Changes |
| Other Study ID Numbers: | TMC-CLV-07-02 |
| Study First Received: | April 22, 2008 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission |
|
Hypertension Hemorrhage Intracranial Pressure Antihypertensive Agent Calcium Channel Blocker |
|
Hemorrhage Hypertension Cerebral Hemorrhage Pathologic Processes Vascular Diseases Cardiovascular Diseases Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Antihypertensive Agents Calcium Channel Blockers Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |