Safety and Efficacy of Nicardipine for the Control of Blo... | NCT00490464

Studies
Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH

NCT00490464

Sponsor

University of Illinois at Chicago

Status

Completed

Last Update Posted

Jun 22, 2007Estimated

Enrollment

163Actual

Phase

Not provided

Conditions

Subarachnoid Hemorrhage
Intracerebral Hemorrhage

Interventions

Nicardipine and Nipride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 21, 2007

First Posted Date

Jun 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2007

Last Update Posted Date

Jun 22, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Name	Type	Description	Arm Group Labels	Other Names
Nicardipine and Nipride	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-70 years old (inclusive)
Admission to NSICU with a diagnosis of SAH or ICH

Exclusion Criteria:

Patients who are admitted >48 hours after SAH or ICH
Readmission or second SAH
Readmission or second ICH
Large (immediately life threatening) associated intraparenchymal or intraventricular hemorrhage
Women who are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Z Roitberg, MD	University of Illinois at Chicago, Department of Neurosurgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois at Chicago, UIC		Chicago	Illinois	60612	United States

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D002543	Cerebral Hemorrhage
D006522	Hepatitis, Infectious Canine

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009529	Nicardipine
D009599	Nitroprusside

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided