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| Name | Class |
|---|---|
| BioMarin Pharmaceutical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrahydrobiopterin 10 mg/kg | Drug | 10mg/kg of Tetrahydrobiopterin daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nitric Oxide bioavailability | Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD). | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis M Messina, MD | UMASS Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMASS Memorial Healthcare - University Campus | Worcester | Massachusetts | 01655 | United States |
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All subjects will receive the same starting dose of the 3 components which will be escalated at day 45.
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| Tetrahydrobiopterin 20 mg/kg | Drug | 20mg/kg of Tetrahydrobiopterin daily. |
|
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| L-Ascorbate | Drug | 3300 mg of l-ascorbate once daily |
|
| L-Arginine | Drug | 3400mg of l-arginine once daily |
|
| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C003402 | sapropterin |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
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