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

NCT01910532 | Withdrawn Phase 4 DMC

• 1 other identifier: 2009H0336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Time to achieve target Systolic Blood Pressure within 30 minutes of start of Celevidipine infusion

  To evaluate the efficacy of Clevidipine for the treatment of acute hypertension during the first 30 minutes after initiation of the intravenous infusion in patients who require an Intracranial Pressure Monitoring Device

  Up to 1 year

Secondary Outcomes (2)

• Percentage of patients who reach target Systolic Blood Pressure within 30 minutes of start of Clevidipine infusion

  Up to 1 year

• Percentage of patients in who the Systolic Blood Pressure is maintained within the target range for up to 3 hours after the first 30 minutes of the start of Clevidipine infusion

  Up to 1 year

Study Arms (1)

Clevidipine

EXPERIMENTAL

Using Clevidipine for the treatment of acute hypertension defined SBP \> 160 mmHg in patients who require an Intracranial Pressure Monitoring Device

Drug: Clevidipine

Interventions

Clevidipine DRUG

Clevidipine for the treatment of acute hypertension defined SBP \> 160 mmHg in patients who require an Intracranial Pressure Monitoring Device

Clevidipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years or older
• Written informed consent from the patient or their legal representative family member before initiation of any study-related procedures
• Patients who clinically require Intracranial Pressure Monitoring device
• Patients who have baseline systolic blood pressure (SBP) (immediately prior to initiation of Clevidipine) \> 160 mmHg measured using an arterial line
• Patients who required IV antihypertensive therapy to achieve SBP ≤ 160 mm Hg

You may not qualify if:

• Patients who are prisoners
• Patients who received an oral antihypertensive medication within 2 hours prior to initiation of Clevidipine
• Patients who received any other IV antihypertensive medication within 2 hours prior to initiation of Clevidipine
• Patients who have fixed dilated pupils and/or absence of gag and oculo-cephalic brain stem reflexes
• Patients with a history of allergy or intolerance to calcium channel blockers
• Patients with a history of allergy to soybean oil or egg lecithin
• Patients who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to enrollment
• Patients who have acute myocardial infarction (AIM) on presentation
• Patients who have known or suspected aortic dissection
• Females who are pregnant or are breastfeeding
• Patients with a history of liver failure, cirrhosis or pancreatitis
• Patients with a prior directive against advanced life support
• Patients with a history of impaired lipid metabolism
• Patients with a history of severe aortic stenosis

Sponsors & Collaborators

• Mario Ammirati: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mario Ammirati, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: July 29, 2013
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

US (1)