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

Who is this study for? Adult patients with peripheral artery disease
What treatments are being studied? Tetrahydrobiopterin+L-Ascorbate+L-Arginine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
UMASS Memorial Healthcare - University Campus
RECRUITING
Worcester
Contact Information
Primary
Shauneen Valliere, MSN
shauneen.valliere@umassmed.edu
508-856-1767
Backup
Mollynda McArthur, MS
mollynda.mcarthur2@umassmed.edu
508-856-2820
Time Frame
Start Date: 2021-06-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 10
Treatments
Experimental: Tetrahydrobiopterin Dose 1 (Day 0 to 44)
All subjects will receive 3300mg l-Ascorbate , l-Arginine 3400mg and 10mg/kg of Tetrahydrobiopterin once a day.
Experimental: Tetrahydrobiopterin Dose 2 (Day 45 to 90)
All subjects will receive 3300mg l-Ascorbate, l-Arginine 3400mg and 20mg/kg of Tetrahydrobiopterin once a day.
Sponsors
Collaborators: BioMarin Pharmaceutical
Leads: Louis Messina

This content was sourced from clinicaltrials.gov