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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00666328 |
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: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Evaluation of Patients With Acute Hypertension and Intracerebral Hemorrhage With Intravenous Clevidipine Treatment |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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. Patients with and an intracerebral hemorrhage (ICH) volume ≤60 cc as well those with an ICH volume >60 cc will be enrolled. Infusion of study drug will be initiated within 6 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 and intraventricular hematoma volumes and measurement of perihematoma edema volume. 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Rootkin | 973-290-6093 | Linda.Rootkin@themedco.com |
Contact: Leisa Waynick | 973-290-6082 | Leisa.Waynick@themedco.com |
United States, District of Columbia | |
Washington Hospital Center | Recruiting |
Washington, District of Columbia, United States, 20010-2975 | |
Contact: Daniel L Herr, MS, MD, FCCM 202-877-7259 daniel.l.herr@Medstar.net | |
Contact: Nazli Bolouri, MD (202) 877-2058 Nazli.Bolouri@MedStar.net | |
Principal Investigator: Daniel L Herr, MS MD FCCM | |
United States, Hawaii | |
The Queens Medical Center | Recruiting |
Honolulu, Hawaii, United States, 96813 | |
Contact: Cherylee Chang, MD 808-537-7152 cchang@queens.org | |
Contact: Tracy Stern, RN, CCRC 808-537-7175 tstern@queens.org | |
Principal Investigator: Cherlylee Chang, MD | |
United States, Maryland | |
The John Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Romergryko Geocadin, MD 410-955-7481 rgeocadi@jhmi.edu | |
Contact: Shannon N LeDroux, B.Sc. (410) 502-0505 sledrou1@jhmi.edu | |
Principal Investigator: Romergryko Geocadin, MD | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Kiwon Lee, MD 212-305-7236 kl2356@columbia.edu | |
Contact: Noeleen Ostapkovich, MS 212-305-4234 NOstapkovich@neuro.columbia.edu | |
Principal Investigator: Kiwon Lee, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Carmelo Graffagnino, MD 919-684-5650 graff002@mc.duke.edu | |
Contact: Joanna Stoner, BSN 919-668-5275 stone034@mc.duke.edu | |
Principal Investigator: Carmelo Graffagnino, MD | |
Guilford Neurologic - Moses H Cone Health System | Recruiting |
Greensboro, North Carolina, United States, 27405 | |
Contact: James Love, MD 336-273-2511 | |
Contact: Patricia Henderson 336-273-2511 PHenderson@guilfordneurologic.com | |
Principal Investigator: James Love, MD | |
United States, Ohio | |
Cleveland Clinic Hospitals | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Gwendolyn Lynch, MD 216-312-4659 lynchg@ccf.org | |
Contact: Rebecca Forkapa, RN 800-223-2273 ext 54488 forkapr@ccf.org | |
Principal Investigator: Gwendolyn Lynch, MD | |
The Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Sergio D Bergese, MD 614-293-9027 bergese.1@osumc.edu | |
Contact: Erika Puente, MD 614-366-8399 erika.puente@osumc.edu | |
Principal Investigator: Sergio D Bergese, MD | |
United States, Pennsylvania | |
Thomas jefferson University Stroke Research | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Prema Krishna, MD 215-503-5646 prema.krishna@jefferson.edu | |
Principal Investigator: Rodney Bell, MD | |
United States, South Carolina | |
Main Medical Center | Not yet recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Tracy Robbins 207-662-2066 scuresearch@mmc.org | |
Contact: Laurel Libby 207-662-2066 scuresearch@mmc.org | |
Principal Investigator: Richard Riker, MD | |
Medical University of South Carolina | Not yet recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Marc LaPointe, BS, PharmD 843-792-2993 lapointe@musc.edu | |
Principal Investigator: Christos Lazaridis, MD | |
United States, Texas | |
The University Health Science Center at S.A. | Recruiting |
San Antonio, Texas, United States, 78229-3900 | |
Contact: Anne D Leonard, BSN MPH 210-567-5625 LEONARDA@uthscsa.edu | |
Contact: Augusto Parra, MD, MPH 210-567-5581 ParraA3@uthscsa.edu | |
Principal Investigator: Augusto Parra, MD, MPH | |
University of Texas Health Science Center at Houston | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: David J Robinson, MD MS FACEP 713-500-7875 david.j.robinson@uth.tmc.edu | |
Contact: Many Robers, DrPH, MPH 713-500-7661 mandy.j.robers@uth.tmc.edu | |
Principal Investigator: David J Robinson, MD MS FACEP | |
United States, Utah | |
Intermountain Medical Center | Recruiting |
Murray, Utah, United States, 84157 | |
Contact: Ben Briggs 801-507-4753 ben.briggs@imail.org | |
Contact: Angela Schwab, MS CGS 801-507-4753 angela.schwabb@imail.org | |
Principal Investigator: John Zurasky, MD | |
Germany | |
Universitatsklinikum Erlangen | Recruiting |
Erlangen, Germany, D91054 | |
Contact: Stefan Schwab, MD 49-9131-85-36597 stefan.schwab@uk-erlangen.de | |
Contact: Andrea-Maria Schickert-Schleicher, RN 49-9131-85-34673 andrea.schickert-schleicher@uk-erlangen.de | |
Principal Investigator: Stefan Schwab, MD | |
Ruprech-Karls University | Recruiting |
Heidelberg, Germany, D69120 | |
Contact: Thorsten Steiner, MD 06221-56-37531 thorsten_steiner@med.uni-heidelberg.de | |
Contact: Pia Petra Schnitzer 06221-56-5496 pia.schnitzer@med.uni-heidelberg.de | |
Principal Investigator: Thorsten Steiner, MD | |
Germany, LEIPZIG | |
Universitätsklinikum Leipzig | Recruiting |
Liebigstraße 22a, LEIPZIG, Germany, D-04103 | |
Contact: Daniela Urban 49-341-97-24206 daniela.urban@medizin.uni-leipzig.de | |
Contact: Ines Gerhardt 49-341-97-24206 ines.gerhardt@medizin.uni-leipzig.de | |
Principal Investigator: Dietmar Schneider, Prof Dr med habil |
Principal Investigator: | Carmelo Graffagnino, MD | Duke University |
Responsible Party: | The Medicines Company ( Linda Rootkin, Director ) |
Study ID Numbers: | TMC-CLV-07-02 |
Study First Received: | April 22, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00666328 History of Changes |
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 Antihypertensive Agent Calcium Channel Blocker |
Calcium, Dietary Cerebral Hemorrhage Vascular Diseases Calcium Channel Blockers Central Nervous System Diseases Intracranial Hemorrhages |
Antihypertensive Agents Brain Diseases Hemorrhage Cerebrovascular Disorders Hypertension |
Cerebral Hemorrhage Pathologic Processes Nervous System Diseases Vascular Diseases Central Nervous System Diseases Cardiovascular Diseases |
Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Hypertension |