Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-30 @ 7:08 PM
Study NCT ID:
NCT00516204
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2007-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Under 70 (Diabetics Below 70)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 685}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-14', 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol levels', 'timeFrame': 'After 4 weeks', 'description': 'Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values'}]}, 'conditionsModule': {'keywords': ['Hyperlipidemia', 'Diabetics', 'NIS', 'Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)'], 'conditions': ['Diabetes', 'Hyperlipidemia', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \\<70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy\n\nExclusion Criteria:\n\n* Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy'}, 'identificationModule': {'nctId': 'NCT00516204', 'briefTitle': 'Diabetic Under 70 (Diabetics Below 70)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Diabetic Under 70 (Diabetics Below 70)', 'orgStudyIdInfo': {'id': 'NIS-CAT-CRE-2007/3'}, 'secondaryIdInfos': [{'id': 'NIS-CAT-DUM-2007/3'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients at very high risk'}, {'label': 'Patients at high risk'}, {'label': 'Patients at medium risk'}, {'label': 'Patients at low risk'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Roden, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chairs of the Austrian Diabetes Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}