Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 8:50 AM
Study NCT ID:
NCT01768403
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Number and percentage of subjects achieving LDL-C goals according to the TJETF guidelines.', 'timeFrame': '24 weeks', 'description': 'In the following sub-populations: - Patients with / or not with metabolic syndrome (according to NCEP III definition), - Primary/secondary prevention patients'}, {'measure': 'Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III/2004 updated NCEP ATP III and to the 2005 AFSSAPS guidelines', 'timeFrame': '24 weeks', 'description': 'Overall and in the following sub-populations: Patients with/or without metabolic syndrome-Iary/IIary preven'}, {'measure': 'Number and percentage of subjects achieving LDL-C goals according to the : TJETF / NCEP ATP III and 2004 updated NCEP ATP III guidelines.', 'timeFrame': '24 weeks', 'description': 'For the following sub-populations: Demographic variables, CV risk factors \\& Lipid-lowering agent class'}, {'measure': 'The association between achievement of LDL-C goals, according to the Third Joint European Task Force / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables, assessed by multivariate logistic regression models', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['Hypercholesterolemia', 'Cardiovascular disease', 'Hypertension', 'Coronary Heart disease', 'Peripheral Arterial disease'], 'conditions': ['Hypercholesterolemia', 'Cardiovascular Disease', 'Hypertension', 'Diabetes', 'Coronary Heart Disease', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.', 'detailedDescription': 'Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Subject must be 19 years of age or older of either gender or race.\n* Subject must provide informed consent and comply with the survey procedures.\n* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must provide informed consent and comply with the survey procedures.\n* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.\n\nExclusion Criteria:\n\n\\- Subjects who are unwilling or unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT01768403', 'acronym': 'CEPHEUS', 'briefTitle': 'Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'NIS-CDZ-XXX-2012/1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Habib BENNACEUR, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}, {'name': 'Nawel BOUTEKDJIRET, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Yassin BOUHOUITA-GUERMECH, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology department /Mustapha Bacha Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}