The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
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- STATUS
- Recruiting
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- End date
- Feb 25, 2023
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- participants needed
- 10
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- sponsor
- University of Massachusetts, Worcester
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.
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.
Details
| Condition | peripheral artery disease, Circulation Disorders, Intermittent Claudication, Vascular Diseases, peripheral arterial diseases, Peripheral Arterial Disease (PAD), Atherosclerosis, peripheral arterial disease, Peripheral Vascular Disease, Claudication, Peripheral vascular disease |
|---|---|
| Treatment | L-arginine, Tetrahydrobiopterin 10 mg/kg, Tetrahydrobiopterin 20 mg/kg, L-Ascorbate, L-Ascorbate |
| Clinical Study Identifier | NCT04800692 |
| Sponsor | University of Massachusetts, Worcester |
| Last Modified on | 25 October 2021 |
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