CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Sodium nitrite +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00873015
NCT00873015Phase 2Completed
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Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm

Hope Pharmaceuticals·interventional·Posted Apr 1, 2009·Updated May 21, 2020

In Brief

A Phase 2 clinical trial evaluating Sodium nitrite and Saline for Subarachnoid Hemorrhage. Completed, enrolled 19 participants across 1 site.

Detailed 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 aneurysms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubarachnoid Hemorrhage
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2009
Enrollment StartApr 1, 2010
Primary CompletionNov 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.3 years ago

Interventions

Sodium nitritedrug

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

Salinedrug

14 day continuous infusion of a vehicle control infusion