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Oral Nitrite Trial for Hypertension and Metabolic Syndrome

NCT02517697 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-19

No results posted yet for this study

Summary

The objective of the study is to investigate effects of inorganic sodium nitrite on the cardiometabolic and hormonal disturbances observed in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction.

Conditions

Interventions

DRUG

14 Nitrogen (N) Sodium Nitrite

oral formulation of sodium nitrite 40 mg three times daily for 12 weeks

DRUG

Placebo

oral formulation of matching placebo three times daily for 12 weeks

Sponsors & Collaborators

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Kara S Hughan, MD · University of Pittsburgh

  • Mark Gladwin, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-04-13
Completion
2021-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02517697 on ClinicalTrials.gov