NCT04800692

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

The Effects of ATLAS (Arginine Tetrahydrobiopterin L-Ascorbate) Therapy on Nitric Oxide Bioavailability and Pain-free Walking in Patients With Intermittent Claudication

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Louis Messina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to show that ATLAS Therapy, (L-Arginine; Tetrahydrobiopterin; L-Ascorbate) is bioavailable in humans and exerts a measurable effect on its in vivo biological signature, Flow Mediated Vasodilation (FMD) in people with intermittent claudication caused by peripheral arterial disease. This will be a Phase I / dose finding study. All subjects will receive 2 different drug doses of the Kuvan the first 45 days they will receive 10 mg/kg/day. The second 45 days they will receive 20/mg/kg/day.

Conditions

• Claudication, Intermittent
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-15
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2021-03-16
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study