Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 6:45 PM
Study NCT ID:
NCT01604733
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-23', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes', 'timeFrame': '24 weeks'}, {'measure': 'The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes', 'timeFrame': '24 weeks'}, {'measure': 'Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia', 'timeFrame': '24 weeks'}, {'measure': 'Physician characteristics associated with the allocation of treatment regimen.', 'timeFrame': '24 weeks'}, {'measure': 'The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multi-Center Survey', 'patients currently on lipid-lowering pharmacological treatment', 'level of Control of Hypercholesterolemia in Egypt'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).', 'detailedDescription': 'Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks\n* Subject must provide informed consent and comply with the survey procedures\n\nExclusion Criteria:\n\n* Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01604733', 'acronym': 'CEPHEUS', 'briefTitle': 'Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'NIS-EG-CRE-2010/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HYPERCHOLESTEROLEMIC PATIENTS'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohie E Sherif, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ethical committee, Faculty of medicine, Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}