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Nitric Oxide Donor

Nitrite + NAC Mix for High Blood Pressure

Phase < 1
Recruiting
Led By Nagababu Enika, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Those whose blood pressure is below normal (i.e., 120/80) and those who have cardiovascular problems and taking organic nitrates and sildenafil-based drugs will also be excluded.
Individuals who are below 21 years of age, pregnant, have major cardiovascular problems or sickle cell disease, incarcerated individuals or are unable to give consent will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to increase nitric oxide levels in the body, reducing blood pressure without developing tolerance, using a mix of sodium nitrite and N-acetylcysteine.

Who is the study for?
This trial is for healthy men and women over 21 who agree to blood draws and blood pressure checks. It's not for those under 21, pregnant, with major heart issues or sickle cell disease, in jail, unable to consent, have low blood pressure or take certain heart medications.
What is being tested?
The study tests a mix of Sodium Nitrite and N-acetylcysteine crystals placed under the tongue to create SNOAC. This may lower high blood pressure without the tolerance seen with some other nitrate drugs.
What are the potential side effects?
Potential side effects are not detailed here but could be similar to other NO donors: headaches, dizziness, flushing or fainting due to lowered blood pressure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure is normal or high, and I'm not on nitrates or sildenafil.
Select...
I am over 21, not pregnant, don't have major heart problems or sickle cell disease, not incarcerated, and can consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measurement of Systemic systolic and diastolic blood pressure
Measurement of plasma nitrite, nitrate and S-nitrosothiols in the study participants.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: sodium nitrite and N-acetycysteine mixtureExperimental Treatment1 Intervention
sodium nitrite 2.5mg + N-acetylcysteine 50mg Sodium nitrite 5 mg + N-acetylcysteine 50mg

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,359 Total Patients Enrolled
Brant Wagener, MD, PhDStudy DirectorUniversity of Alabama at Birmingham
Nagababu Enika, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crystals (Nitric Oxide Donor) Clinical Trial Eligibility Overview. Trial Name: NCT05798481 — Phase < 1
Cardiovascular Disease Research Study Groups: sodium nitrite and N-acetycysteine mixture
Cardiovascular Disease Clinical Trial 2023: Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crystals Highlights & Side Effects. Trial Name: NCT05798481 — Phase < 1
Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crystals (Nitric Oxide Donor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05798481 — Phase < 1
~7 spots leftby Sep 2025
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