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Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hope Pharmaceuticals
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00873015
First received: March 31, 2009
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Pharmacokinetic of a 14 day infusion of sodium nitrite [ Time Frame: multiple time points up to the end of day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety of a 14 day infusion of sodium nitrite [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • efficacy of 14 day infusion of sodium nitrite [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitrite Drug: Sodium nitrite
14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
Placebo Comparator: Vehicle control Drug: Nitrite
14 day continuous infusion of a vehicle control infusion

  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    
Sponsors and Collaborators
University of Virginia
Hope Pharmaceuticals
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Edward Oldfield, MD University of Virginia
  More Information

No publications provided

Responsible Party: Edward H. Oldfield, MD, Department of Neurological Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT00873015     History of Changes
Other Study ID Numbers: 14024, 1 R44 NSO63485-01
Study First Received: March 31, 2009
Last Updated: April 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Cerebral aneurysm
Subarachnoid hemorrhage
Nitrite

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013