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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
1,590 Previous Clinical Trials
2,281,648 Total Patients Enrolled
Nagababu Enika, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Brant Wagener, MD, PhDStudy DirectorUniversity 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
High Blood Pressure Research Study Groups: sodium nitrite and N-acetycysteine mixture
High Blood Pressure 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial include elderly individuals aged 75 and over?

"According to the study's criteria, prospective participants must be between 21 and 80 years old. Alternatively, there are 77 trials for minors and 983 specifically catered towards seniors."

Answered by AI

What qualifications must be met to enroll in this trial?

"Applicants must have hypertension and be between the ages of 21-80 to qualify for this study. A total of 14 patients are desired by the research team."

Answered by AI

Are there any vacancies left for volunteers in this experiment?

"As stated on clinicaltrials.gov, this medical research is currently not accepting any new candidates. This trial was initially posted June 1st 2023 and has since been updated March 23rd of the same year; although, a plethora of other trials are actively recruiting participants at present."

Answered by AI
~9 spots leftby Sep 2025