Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT01075594
Status:
COMPLETED
Last Update Posted:
2010-09-10
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 'whole blood, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-09', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines', 'timeFrame': '6 months - one visit only, no follow-up visits'}], 'secondaryOutcomes': [{'measure': 'The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets', 'timeFrame': '6 months - one visit only, no follow-up visits'}, {'measure': 'The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets', 'timeFrame': '6 months - one visit only, no follow-up visits'}, {'measure': 'The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL', 'timeFrame': '6 months - one visit only, no follow-up visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'Target cholesterol', 'Undertreatment'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Informed Consent not provided'}, 'identificationModule': {'nctId': 'NCT01075594', 'acronym': 'CEPHEUS', 'briefTitle': 'Study of Undertreatment of Patients With Dyslipidemia in Bulgaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'NIS-CBG-CRE-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with dyslipidemia on lipid lowering therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blagoevgrad', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 41.93415, 'lon': 25.55557}}, {'city': 'Montana', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41285, 'lon': 23.22174}}, {'city': 'Pazardzhik', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.19934, 'lon': 24.33318}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Shumen', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.27064, 'lon': 26.92286}}, {'city': 'Sliven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.68607, 'lon': 26.32558}}, {'city': 'Smolyan', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 41.57439, 'lon': 24.71204}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Veliko Tarnovo', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.08124, 'lon': 25.62904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}