Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT00785460
Status:
COMPLETED
Last Update Posted:
2008-11-05
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C013835', 'term': 'benphothiamine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'lastUpdateSubmitDate': '2008-11-04', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated dilatation', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Laboratory markers of endothelial function', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the brachial artery.', 'detailedDescription': 'Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation (FMD) of the brachial arteryand laboratory parameters (adhesion molecules).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy habitual smokers\n\nExclusion Criteria:\n\n* any kind of chronic disease'}, 'identificationModule': {'nctId': 'NCT00785460', 'briefTitle': 'Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers', 'orgStudyIdInfo': {'id': 'Benfo Smoker'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benfotiamine and Smoking', 'interventionNames': ['Drug: Benfotiamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Smoking alone', 'interventionNames': ['Drug: Benfotiamine']}], 'interventions': [{'name': 'Benfotiamine', 'type': 'DRUG', 'armGroupLabels': ['Benfotiamine and Smoking', 'Smoking alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Heart and Diabetes Center', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}], 'overallOfficials': [{'name': 'Alin Stirban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr-University Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alin Stirban', 'oldOrganization': 'Heart and Diabetes Center NRW'}}}}