Status:
RECRUITING
The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
Lead Sponsor:
Louis Messina
Collaborating Sponsors:
BioMarin Pharmaceutical
Conditions:
Claudication, Intermittent
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 i...
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 sig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04800692
Start Date
June 15 2021
End Date
December 1 2027
Last Update
April 6 2025
Active Locations (1)
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1
UMASS Memorial Healthcare - University Campus
Worcester, Massachusetts, United States, 01655