A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

This study has been completed.

Sponsor:

Collaborator:

The Medicines Company

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT00952081

First received: July 29, 2009

Last updated: January 26, 2015

Last verified: January 2015

History of Changes

Results First Received: June 22, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hypertension Brain Tumor Epilepsy
Intervention:	Drug: Clevidipine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients scheduled for intracranial surgery were prospectively enrolled after giving consent. Clevidipine (0.5 mg/mL in 20% lipid solution, which was to be initiated at 10 mg/h and titrated to effect) was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Clevidipine,Brain Tumor,Hypertension	Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Participant Flow: Overall Study

	Clevidipine,Brain Tumor,Hypertension
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Clevidipine,Brain Tumor,Hypertension	21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia

Baseline Measures

	Clevidipine,Brain Tumor,Hypertension
Number of Participants [units: participants]	22
Age [units: participants]
<=18 years	0
Between 18 and 65 years	21
>=65 years	1
Age [units: years] Mean (Standard Deviation)	54 (14.25)
Gender [units: participants]
Female	12
Male	10
Region of Enrollment [units: participants]
United States	22

Outcome Measures

1. Primary:

The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control) [ Time Frame: intraoperatively and 90 min after surgery ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Alex Bekker, MD, PhD
Organization: UMDNJ
phone: 973-972-5007
e-mail: bekkeray@umdnj.edu

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00952081 History of Changes
Other Study ID Numbers:	08-745
Study First Received:	July 29, 2009
Results First Received:	June 22, 2012
Last Updated:	January 26, 2015
Health Authority:	United States: Institutional Review Board

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