Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT05458232
Status:
WITHDRAWN
Last Update Posted:
2024-11-04
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood/plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal voluntary contraction of lower leg.', 'timeFrame': '14 days', 'description': 'Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil'}], 'secondaryOutcomes': [{'measure': 'Change in muscle Fatigue', 'timeFrame': '14 days', 'description': 'A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '9164280', 'type': 'BACKGROUND', 'citation': 'Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.'}]}, 'descriptionModule': {'briefSummary': 'This study will be the first demonstration of the utility and feasibility of Phosphodiesterase Type 5 inhibitor as an effective pharmacological therapy for improving anabolic resistant states.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males 60-75 years who have been prescribed 5mg daily tadalafil by their physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 60-75 yrs\n* Recently prescribed 5mg of tadalafil daily for clinical purposes\n\nExclusion Criteria:\n\n* History of diabetes\n* history of hypotension including orthostatic hypotension\n* History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment\n* History of short gut syndrome, gastrointestinal bypass/reduction surgery (Lap band, gastric sleeve, etc.)\n* Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2 and 3.\n* Alcohol consumption of ≥ 5 units/servings per day\n* Concomitant use of\n\n * oral or injectable corticosteroids\n * testosterone, insulin like growth factor-1, or similar anabolic agent\n * riociguat (Adempas)\n * nitroglycerin\n * isosorbide dinitrate (Isordil)\n * isosorbide mononitrate (Imdur, Monoket)\n * doxazosin (Cardura)\n * prazosin (Minipress)\n * terazosin (Hytrin)\n* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician'}, 'identificationModule': {'nctId': 'NCT05458232', 'briefTitle': 'Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults', 'orgStudyIdInfo': {'id': '273780'}}, 'armsInterventionsModule': {'armGroups': [{'label': '5mg tadalafil once daily for 14 days', 'interventionNames': ['Drug: Tadalafil 5mg']}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': 'Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.', 'armGroupLabels': ['5mg tadalafil once daily for 14 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}