Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 10:18 PM
Study NCT ID:
NCT04800692
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003402', 'term': 'sapropterin'}, {'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All subjects will receive the same starting dose of the 3 components which will be escalated at day 45.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nitric Oxide bioavailability', 'timeFrame': '90 days', 'description': 'Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Claudication, Intermittent', 'Peripheral Artery Disease', 'Peripheral Vascular Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Rutherford Classification II, III\n* Age \\>18 years old\n* Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio\n* Willingness to discontinue phosphodiesterase (PDE) 3inhibitors cilostazol, milrinone or Vesnarinone\n* Willing and able to comply with all study procedures\n* Willing and able to provide informed consent\n* Sexually active subjects willing to use an acceptable method of contraception while participating in the study\n\nExclusion Criteria:\n\n* Hypotension defined as a systolic blood pressure less than 100mmhg systolic at screening or baseline visit\n* Critical Leg Ischemia (Rutherford Classification IV, V, VI)\n* 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\n* Walking limited by reasons other than claudication (e.g. arthritis, lung disease, severe neuropathy, lower extremity amputation except single digits)\n* Serum creatinine \\>1.5mg/dl or Hepatic enzymes \\>2X the upper limit of normal\n* Serum potassium greater than 5.0 or use of a potassium sparing diuretic at screening\n* Pregnant, breast feeding or planning to become pregnant (subject or partner) at any time during the study.\n* Myocardial Infarction, Cerebrovascular Accident or deep vein thrombosis within 12 months of screening\n* Known history of nephrolithiasis\n* History of ever having a seizure\n* 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\n* History of vertigo or syncope within the past 10 years\n* Enrollment in another drug or device study within 30 days of screening\n* Required treatment with a drug known to inhibit folate metabolism (e.g. Methotrexate)\n* Taking any of the following medications; PDE3 Inhibitors, PDE5 inhibitors, trental, nitrates, ginkgo biloba, levodopa, warfarin,\n* Axillary lymph node dissection\n* Presence of an amputation except single digits in either leg\n* Preexisting illness that limits ambulation such as severe COPD, class III-IV heart failure, severe arthritis or back pain\n* Glucose-6-dehydrogenase deficiency'}, 'identificationModule': {'nctId': 'NCT04800692', 'acronym': 'ATLAS', 'briefTitle': 'The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'The Effects of ATLAS (Arginine Tetrahydrobiopterin L-Ascorbate) Therapy on Nitric Oxide Bioavailability and Pain-free Walking in Patients With Intermittent Claudication', 'orgStudyIdInfo': {'id': 'H00012734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetrahydrobiopterin Dose 1 (Day 0 to 44)', 'description': 'All subjects will receive 3300mg l-Ascorbate , l-Arginine 3400mg and 10mg/kg of Tetrahydrobiopterin once a day.', 'interventionNames': ['Drug: Tetrahydrobiopterin 10 mg/kg', 'Drug: L-Ascorbate', 'Drug: L-Arginine']}, {'type': 'EXPERIMENTAL', 'label': 'Tetrahydrobiopterin Dose 2 (Day 45 to 90)', 'description': 'All subjects will receive 3300mg l-Ascorbate, l-Arginine 3400mg and 20mg/kg of Tetrahydrobiopterin once a day.', 'interventionNames': ['Drug: Tetrahydrobiopterin 20 mg/kg', 'Drug: L-Ascorbate', 'Drug: L-Arginine']}], 'interventions': [{'name': 'Tetrahydrobiopterin 10 mg/kg', 'type': 'DRUG', 'otherNames': ['sapropterin', 'kuvan'], 'description': '10mg/kg of Tetrahydrobiopterin daily.', 'armGroupLabels': ['Tetrahydrobiopterin Dose 1 (Day 0 to 44)']}, {'name': 'Tetrahydrobiopterin 20 mg/kg', 'type': 'DRUG', 'otherNames': ['sapropterin', 'kuvan'], 'description': '20mg/kg of Tetrahydrobiopterin daily.', 'armGroupLabels': ['Tetrahydrobiopterin Dose 2 (Day 45 to 90)']}, {'name': 'L-Ascorbate', 'type': 'DRUG', 'description': '3300 mg of l-ascorbate once daily', 'armGroupLabels': ['Tetrahydrobiopterin Dose 1 (Day 0 to 44)', 'Tetrahydrobiopterin Dose 2 (Day 45 to 90)']}, {'name': 'L-Arginine', 'type': 'DRUG', 'description': '3400mg of l-arginine once daily', 'armGroupLabels': ['Tetrahydrobiopterin Dose 1 (Day 0 to 44)', 'Tetrahydrobiopterin Dose 2 (Day 45 to 90)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shauneen Valliere, MSN', 'role': 'CONTACT', 'email': 'shauneen.valliere@umassmed.edu', 'phone': '508-856-1767'}, {'name': 'Mollynda McArthur, MS', 'role': 'CONTACT', 'email': 'mollynda.mcarthur2@umassmed.edu', 'phone': '508-856-2820'}], 'facility': 'UMASS Memorial Healthcare - University Campus', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Shauneen Valliere, MSN', 'role': 'CONTACT', 'email': 'shauneen.valliere@umassmed.edu', 'phone': '508-856-1767'}, {'name': 'Mollynda McArthur, MS', 'role': 'CONTACT', 'email': 'mollynda.mcarthur2@umassmed.edu', 'phone': '508-856-2820'}], 'overallOfficials': [{'name': 'Louis M Messina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMASS Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louis Messina', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioMarin Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Louis Messina', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}