Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage (CLASH)
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|ClinicalTrials.gov Identifier: NCT00978822|
Recruitment Status : Unknown
Verified September 2009 by Henry Ford Health System.
Recruitment status was: Recruiting
First Posted : September 17, 2009
Last Update Posted : September 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage Hypertension||Drug: Clevidipine butyrate injectable emulsion||Phase 2|
This is a single center, 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 aneurysmal subarachnoid hemorrhage. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as a range of SBP to be controlled within immediately prior to initiation of study drug. Approximately 20 patients with acute A SAH will be enrolled. Infusion of study drug will be initiated as soon ass the patient arrives in the ER and diagnosis is made and consent is obtained. 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 90 seconds. Thereafter, titration to higher infusion rates can be attempted as needed q90 seconds to obtain the target SBP range.
Titration to effect is to proceed by doubling the dose every 90 seconds, 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 48 hours. Blood pressure and ICP recording will be recorded q 5 minutes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||June 2010|
|Experimental: Clevidipine butyrate injectable emulsion||
Drug: Clevidipine butyrate injectable emulsion
Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
Other Name: Cleviprex
- Ability to control and maintain blood pressure within a certain range by the drug infusion. [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978822
|Contact: Panayiotis N Varelas, MD PhDfirstname.lastname@example.org|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Kathleen Wilson, Bsc, RN 313-916-3501 email@example.com|
|Principal Investigator: Panayiotis N Varelas, MD, PhD|
|Sub-Investigator: Tamer Abdelhak, MD|
|Principal Investigator:||Panayiotis N Varelas, MD PhD||Henry Ford Hospital|