Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT01023503
Status:
WITHDRAWN
Last Update Posted:
2013-07-24
First Post:
2009-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study To Evaluate Statins Patterns Of Use In Spain
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2009-10-31', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current and previous hypolipemic treatment, dose and pattern', 'timeFrame': 'Retrospectively (information for the previous 6-months). Information collected once.'}, {'measure': 'Statin treatment start date, origin of the prescription, reasons for changes in prescription', 'timeFrame': 'Retrospectively (information for the previous 6-months). Information collected once.'}], 'secondaryOutcomes': [{'measure': 'Socio-demographic characteristics', 'timeFrame': 'retrospectively'}, {'measure': 'Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels', 'timeFrame': 'retrospectively'}, {'measure': 'Concomitant Treatments and Cardiovascular History', 'timeFrame': 'retrospectively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statins', 'Dyslipidemia', 'Spain', 'Rosuvastatin', 'Naive', 'Switching', 'New statins prescriptions in Spain (naive patients and switching)'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To be recruited by Primary Care Physicians', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving a new statin prescription (naïve patients)\n* Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)\n\nExclusion Criteria:\n\n* Patients without enough information in the medical records to complete the fields required in the eCRF'}, 'identificationModule': {'nctId': 'NCT01023503', 'briefTitle': 'Observational Study To Evaluate Statins Patterns Of Use In Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Statins Use Patterns in Spain', 'orgStudyIdInfo': {'id': 'NIS-CES-CRE-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Adults, with a new statin prescription or a change in their stain treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fundació Institut Català de Farmacologia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}