Status:
COMPLETED
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
Lead Sponsor:
Hope Pharmaceuticals
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 aneu...
Detailed Description
Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite...
Eligibility Criteria
Inclusion
- Ruptured cerebral aneurysm
Exclusion
- Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00873015
Start Date
April 1 2010
End Date
August 1 2012
Last Update
May 21 2020
Active Locations (1)
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1
University of Virginia Health System Medical Center
Charlottesville, Virginia, United States, 22903