The Evaluation of Clevidipine in Patients Requiring ICP Monitoring & IV

Status Withdrawn

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT01910532
Study type	Interventional
Source	Ohio State University
Contact
Status	Withdrawn
Phase	Phase 4
Start date	April 2010
Completion date	November 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms