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

H00012734

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.

2021-06-15

2025-07-01

2025-12-01

Recruiting

Early phase I

10

Inclusion Criteria: * PAD as demonstrated by an ABI \<0 .9 in one leg or TBI less than \<0.7 in patients with an ABI \>1.3 (non compressible vessels) * Rutherford Classification II, III * Age \>18 years old * Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio * Willingness to discontinue phosphodiesterase (PDE) 3inhibitors cilostazol, milrinone or Vesnarinone * Willing and able to comply with all study procedures * Willing and able to provide informed consent * Sexually active subjects willing to use an acceptable method of contraception while participating in the study Exclusion Criteria: * Hypotension defined as a systolic blood pressure less than 100mmhg systolic at screening or baseline visit * Critical Leg Ischemia (Rutherford Classification IV, V, VI) * Surgical intervention to alleviate symptoms of claudication in the study leg within the past 6 months or any endovascular interventions within 3 months or who is scheduled to undergo surgical revascularization in the next 6 month * Walking limited by reasons other than claudication (e.g. arthritis, lung disease, severe neuropathy, lower extremity amputation except single digits) * Serum creatinine \>1.5mg/dl or Hepatic enzymes \>2X the upper limit of normal * Serum potassium greater than 5.0 or use of a potassium sparing diuretic at screening * Pregnant, breast feeding or planning to become pregnant (subject or partner) at any time during the study. * Myocardial Infarction, Cerebrovascular Accident or deep vein thrombosis within 12 months of screening * Known history of nephrolithiasis * History of ever having a seizure * Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, organ transplant, long term immunosuppression (excluding inhaled steroids), current neoplasm or severe gastroesophageal reflux * History of vertigo or syncope within the past 10 years * Enrollment in another drug or device study within 30 days of screening * Required treatment with a drug known to inhibit folate metabolism (e.g. Methotrexate) * Taking any of the following medications; PDE3 Inhibitors, PDE5 inhibitors, trental, nitrates, ginkgo biloba, levodopa, warfarin, * Axillary lymph node dissection * Presence of an amputation except single digits in either leg * Preexisting illness that limits ambulation such as severe COPD, class III-IV heart failure, severe arthritis or back pain * Glucose-6-dehydrogenase deficiency

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All subjects will receive the same starting dose of the 3 components which will be escalated at day 45.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2023-11-18