Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04800692 | The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication | PHASE1 | ACTIVE NOT_RECRUITING | 10 | — | — | Jun 15, 2021 | Dec 1, 2027 | Apr 15, 2026 | 1 | United States |
Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD).
| Arm | Type | Description |
|---|---|---|
| Tetrahydrobiopterin Dose 1 (Day 0 to 44) | EXPERIMENTAL | All subjects will receive 3300mg l-Ascorbate , l-Arginine 3400mg and 10mg/kg of Tetrahydrobiopterin once a day. |
| Tetrahydrobiopterin Dose 2 (Day 45 to 90) | EXPERIMENTAL | All subjects will receive 3300mg l-Ascorbate, l-Arginine 3400mg and 20mg/kg of Tetrahydrobiopterin once a day. |
| Name | Type | Description |
|---|---|---|
| Tetrahydrobiopterin 10 mg/kg | DRUG | 10mg/kg of Tetrahydrobiopterin daily. |
| Tetrahydrobiopterin 20 mg/kg | DRUG | 20mg/kg of Tetrahydrobiopterin daily. |
| L-Ascorbate | DRUG | 3300 mg of l-ascorbate once daily |
| L-Arginine | DRUG | 3400mg of l-arginine once daily |
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, Le...