Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT00427960
Status:
TERMINATED
Last Update Posted:
2010-12-16
First Post:
2007-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AZTrial_Results_Posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'Astrazeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study achieved only 8% of the randomised target number of patients and for this reason alone was terminated early. Planned statistical analyses could not be performed. No scientifically valid conclusions can be drawn from the limited study data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg', 'otherNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg', 'otherNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '33.28', 'groupId': 'OG000'}, {'value': '36.92', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Calculated as LDL-C at Week 6 - LDL-C at Week 12\\] \\* 100', 'unitOfMeasure': 'Percent Change in LDL-C', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (Baseline) and 12 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': "The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Risk categories are:\n\nSymptomatic Asymptomatic, total risk \\<5% Asymptomatic, total risk ≥5%, baseline LDL-C\\<3 mmol/L and baseline TC\\<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L\n\nPatients are defined as symptomatic if they meet at least 1 of the following criteria:\n\nHistory of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg\n\nTotal risk is derived from age, sex, TC, systolic BP and smoking status.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline(week6) in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.03', 'groupId': 'OG000'}, {'value': '-26.88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in TC', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.46', 'groupId': 'OG000'}, {'value': '3.15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in HDL-C', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6)in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.72', 'groupId': 'OG000'}, {'value': '-34.09', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in Non-HDL-C', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.96', 'groupId': 'OG000'}, {'value': '-28.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in ApoB', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000'}, {'value': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in ApoA1', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.75', 'groupId': 'OG000'}, {'value': '-38.45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in LDL-C/HDL-C Ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.99', 'groupId': 'OG000'}, {'value': '-28.42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in TC/HDL-C Ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.05', 'groupId': 'OG000'}, {'value': '-35.48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in Non-HDL-C/HDL-C Ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.89', 'groupId': 'OG000'}, {'value': '-28.75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6', 'unitOfMeasure': 'Percent Change in ApoB/ApoA1 Ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Risk categories are:\n\nSymptomatic Asymptomatic, total risk \\<5% Asymptomatic, total risk ≥5%, baseline LDL-C\\<3 mmol/L and baseline TC\\<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L\n\nPatients are defined as symptomatic if they meet at least 1 of the following criteria:\n\nHistory of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg\n\nTotal risk is derived from age, sex, TC, systolic BP and smoking status.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population (all randomized patients).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'FG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007.', 'preAssignmentDetails': 'Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rosuvastatin', 'description': 'rosuvastatin 5 mg'}, {'id': 'BG001', 'title': 'Atorvastatin', 'description': 'atorvastatin 10 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '11', 'groupId': 'BG000'}, {'value': '53', 'spread': '11', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'whyStopped': 'Due to inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2007-01-25', 'resultsFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2007-01-25', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-08', 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Calculated as LDL-C at Week 6 - LDL-C at Week 12\\] \\* 100'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L', 'timeFrame': '6 weeks (Baseline) and 12 weeks'}, {'measure': "The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L", 'timeFrame': '6 weeks (baseline) and 12 weeks'}, {'measure': 'The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Risk categories are:\n\nSymptomatic Asymptomatic, total risk \\<5% Asymptomatic, total risk ≥5%, baseline LDL-C\\<3 mmol/L and baseline TC\\<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L\n\nPatients are defined as symptomatic if they meet at least 1 of the following criteria:\n\nHistory of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg\n\nTotal risk is derived from age, sex, TC, systolic BP and smoking status.'}, {'measure': 'The Percentage Change From Baseline(week6) in TC', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L', 'timeFrame': '6 weeks (baseline) and 12 weeks'}, {'measure': 'The Percentage Change From Baseline (Week 6)in Non-HDL-C', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Derived according to the following formula: 100\\*\\[Lipid at week 12 - Lipid at week 6\\]/Lipid at week 6'}, {'measure': 'The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.', 'timeFrame': '6 weeks (baseline) and 12 weeks', 'description': 'Risk categories are:\n\nSymptomatic Asymptomatic, total risk \\<5% Asymptomatic, total risk ≥5%, baseline LDL-C\\<3 mmol/L and baseline TC\\<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L\n\nPatients are defined as symptomatic if they meet at least 1 of the following criteria:\n\nHistory of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg\n\nTotal risk is derived from age, sex, TC, systolic BP and smoking status.'}]}, 'conditionsModule': {'keywords': ['cholesterol', 'statin', 'Asian', 'LDL-cholesterol'], 'conditions': ['Hypercholesterolaemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian patients in the UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self described Asian, first or second generation\n* Male or female \\> or = 18 years with primary hypercholesterolaemia.\n\nExclusion Criteria:\n\n* Use of cholesterol lowering drugs from visit 1\n* Homozygous familial hypercholesterolaemia\n* Active arterial disease within 3 months of study entry\n* Poorly controlled diabetes\n* Uncontrolled hypothyroidism\n* Active liver disease\n* History of alcoh/drug abuse.'}, 'identificationModule': {'nctId': 'NCT00427960', 'briefTitle': 'Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IV, 6-week, Randomised, Double-blind, Multicentre, Parallel Group, Comparative Study to Evaluate the Efficacy of Rosuvastatin 5mg and Atorvastatin 10mg in UK Asian Subjects With Primary Hypercholesterolaemia', 'orgStudyIdInfo': {'id': 'D3560L00060'}, 'secondaryIdInfos': [{'id': 'SHUKRA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rosuvastatin', 'description': 'rosuvastatin 5 mg', 'interventionNames': ['Behavioral: Dietary advice', 'Drug: rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'atorvastatin', 'description': 'atorvastatin 10 mg', 'interventionNames': ['Behavioral: Dietary advice', 'Drug: atorvastatin']}], 'interventions': [{'name': 'Dietary advice', 'type': 'BEHAVIORAL', 'armGroupLabels': ['atorvastatin', 'rosuvastatin']}, {'name': 'rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'rosuvastatin 5 mg', 'armGroupLabels': ['rosuvastatin']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'atorvastatin 10 mg', 'armGroupLabels': ['atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Allerton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36697, 'lon': -2.894}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Blackburn', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Crawley', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research SIte', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Research SIte', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Slough', 'country': 'United Kingdom', 'facility': 'Research SIte', 'geoPoint': {'lat': 51.50949, 'lon': -0.59541}}], 'overallOfficials': [{'name': 'Rhiannon Rowsell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Shahid Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bradford PCT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}