Phase 2
N=19
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
Subarachnoid Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00873015 ↗Enrolled (actual)
19
Serious AEs
11.1%
Results posted
Jul 2013
Primary outcome: Primary: Mean Plasma Nitrite Concentration (Micromol/L) — 4.2; 4.3; 2.6 micromol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium nitrite (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hope Pharmaceuticals
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Nitrite Concentration (Micromol/L) |
4.2; 4.3; 2.6 | — |
| SECONDARY Safety of a 14 Day Infusion of Sodium Nitrite |
0; 0; 0; 0 | — |
| SECONDARY Efficacy of 14 Day Infusion of Sodium Nitrite |
1; 1; 0; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ruptured cerebral aneurysm
Exclusion Criteria
- Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Data sourced from ClinicalTrials.gov (NCT00873015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.