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The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

NCT04800692 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-15

No results posted yet for this study

Summary

This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physical activity.

Conditions

Interventions

DRUG

Tetrahydrobiopterin 10 mg/kg

10mg/kg of Tetrahydrobiopterin daily.

DRUG

Tetrahydrobiopterin 20 mg/kg

20mg/kg of Tetrahydrobiopterin daily.

DRUG

L-Ascorbate

3300 mg of l-ascorbate once daily

DRUG

L-Arginine

3400mg of l-arginine once daily

Sponsors & Collaborators

Principal Investigators

  • Louis M Messina, MD · UMASS Medical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04800692 on ClinicalTrials.gov