Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

This study is currently recruiting participants.

Verified by University of Virginia, March 2009

First Received: March 31, 2009 Last Updated: May 26, 2009 History of Changes

Sponsors and Collaborators:	University of Virginia Hope Pharmaceuticals National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00873015

Purpose

The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Condition	Intervention	Phase
Cerebral Vasospasm After Subarachnoid Hemorrhage.	Drug: Sodium nitrite Drug: Nitrite	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:	Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms

Drug Information available for: Sodium nitrite

U.S. FDA Resources

Further study details as provided by University of Virginia:

Study Start Date:

April 2009

Arms	Assigned Interventions
Nitrite: Experimental	Drug: Sodium nitrite
Vehicle control: Placebo Comparator	Drug: Nitrite

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ruptured cerebral aneurysm

Exclusion Criteria:

Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873015

Contacts

Contact: Edward H Oldfield, MD	434-295-0750	eho4u@virginia.edu
Contact: Edward Oldfield	434-295-0750	eho4u@virginia.edu

Locations

United States, Virginia
University of Virginia Health System Medical Center	Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Edward Oldfield 434-295-0750 eho4u@virginia.edu
Contact: Edward Oldfield 434-295-0750 eho4u@virginia.edu

Sponsors and Collaborators

University of Virginia

Hope Pharmaceuticals

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

No publications provided

Responsible Party:	Department of Neurological Surgery, University of Virginia ( Edward H. Oldfield, MD )
Study ID Numbers:	1 R44 NSO63485-01
Study First Received:	March 31, 2009
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00873015 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Virginia:

Cerebral aneurysm
Subarachnoid hemorrhage
Nitrite

Study placed in the following topic categories:

Cerebral Aneurysm
Aneurysm
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases

Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Vasospasm, Intracranial

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases
Cardiovascular Diseases

Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Vasospasm, Intracranial

ClinicalTrials.gov processed this record on September 02, 2009