Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-29 @ 2:03 PM
Study NCT ID:
NCT01910532
Status:
WITHDRAWN
Last Update Posted:
2013-07-29
First Post:
2011-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
Sponsor:
Mario Ammirati
Organization:
Study Overview
Official Title:
The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor discontinued the research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
Detailed Description:
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
All patients in which ICP monitoring is carried out need to maintain Cerebral Perfusion Pressure (CPP) within a tight range (typically, 70-90 mmHg) in order to avoid secondary brain injuries related to either too high or too low CPP. In this context there are clear benefits associated with a medication that is able to control hypertensive situations quickly and that lends itself to easy and reliable modulation.
Clinical studies have demonstrated that Clevidipine is an effective antihypertensive agent with a rapid onset and offset of action, and a favorable safety profile. Clevidipine has a predictable dose-response profile and is readily titrated to achieve individualized pharmacodynamic effects.
The investigators reasoned that Clevidipine could be an effective anti-hypertensive agent in this cohort of patients in which there is a need for rapid and precise blood pressure control. It is further hypothesized that improved blood pressure control in this patient population may result in the reduction in the severity of their neurological impairment.
The question to be answered is as follows: Is Clevidipine highly effective in achieving and maintaining Blood Pressure control in patients with hypertension (Systolic Blood Pressure \> 160 mm Hg) and who require an Intracranial Pressure Monitoring Device?
Clevidipine will be highly effective in achieving and maintaining Blood Pressure control in patients with hypertension and who require an Intracranial Pressure Monitoring Device.
All patients in which ICP monitoring is carried out need to maintain Cerebral Perfusion Pressure (CPP) within a tight range (typically, 70-90 mmHg) in order to avoid secondary brain injuries related to either too high or too low CPP. In this context there are clear benefits associated with a medication that is able to control hypertensive situations quickly and that lends itself to easy and reliable modulation.
Clinical studies have demonstrated that Clevidipine is an effective antihypertensive agent with a rapid onset and offset of action, and a favorable safety profile. Clevidipine has a predictable dose-response profile and is readily titrated to achieve individualized pharmacodynamic effects.
The investigators reasoned that Clevidipine could be an effective anti-hypertensive agent in this cohort of patients in which there is a need for rapid and precise blood pressure control. It is further hypothesized that improved blood pressure control in this patient population may result in the reduction in the severity of their neurological impairment.
The question to be answered is as follows: Is Clevidipine highly effective in achieving and maintaining Blood Pressure control in patients with hypertension (Systolic Blood Pressure \> 160 mm Hg) and who require an Intracranial Pressure Monitoring Device?
Clevidipine will be highly effective in achieving and maintaining Blood Pressure control in patients with hypertension and who require an Intracranial Pressure Monitoring Device.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: