Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00931320
Status:
COMPLETED
Last Update Posted:
2009-10-27
First Post:
2009-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients
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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-23', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment)', 'timeFrame': 'After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.'}], 'secondaryOutcomes': [{'measure': 'Evaluate difference of LDL/HDL ratio among different statins & dosages (between baseline & after treatment)', 'timeFrame': 'After Treatment : at least 4 weeks before statin taking / Baseline : no limitation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ratio improvement', 'LDL-C', 'HDL-C', 'Ratio of Low Density Lipoprotein Cholesterol to High Density Lipoprotein Cholesterol Improvement', 'High Density Lipoprotein Cholesterol'], 'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Who have at least made 1 visit to the outpatient clinic within previous 6 months .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia\n* Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months\n* Subjects who have records of both LDL-C and HDL-C before \\& after statin treatment (at least four weeks after statin taking)\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to provide their examination and lab result of medical chart.'}, 'identificationModule': {'nctId': 'NCT00931320', 'acronym': 'RACHEL', 'briefTitle': 'Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients', 'orgStudyIdInfo': {'id': 'NIS-CKR-DUM-2009/3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3000 patients', 'description': 'Who have at least made 1 visit to the outpatient clinic within previous 6 months .'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hyunah Caroline Choi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hyunah Caroline, Choi / CV TA Physician', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}