At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
14Nitrogen Sodium Nitritedrug
Likely dose
14Nitrogen Sodium Nitrite 40 mgfrom 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.
An Open-Label Study of Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
In Brief
A Phase 2 clinical trial evaluating 14Nitrogen Sodium Nitrite for Metabolic Syndrome and Hypertension. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This research study is being conducted to examine the effects of daily inorganic nitrite treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy may have a major impact on the prevention and treatment of both diabetes and cardiovascular disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome, Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionFeb 2018
Study CompletionMar 2018
TodayJul 2026
First PostedSep 10, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 8, 2018
Study CompletionMar 8, 2018
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.8 years ago
Interventions
14Nitrogen Sodium Nitritedrug
oral formulation of sodium nitrite 40 mg three times a day for 12 weeks