Title
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
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
Phase
Phase 4Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
HypercholesterolaemiaIntervention/Treatment
rosuvastatin atorvastatin ...Study Participants
55The 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.
rosuvastatin 5 mg
atorvastatin 10 mg
Inclusion Criteria: Self described Asian, first or second generation Male or female > or = 18 years with primary hypercholesterolaemia. Exclusion Criteria: Use of cholesterol lowering drugs from visit 1 Homozygous familial hypercholesterolaemia Active arterial disease within 3 months of study entry Poorly controlled diabetes Uncontrolled hypothyroidism Active liver disease History of alcoh/drug abuse.
| Event Type | Organ System | Event Term | Rosuvastatin | Atorvastatin |
|---|
Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100
Risk categories are: Symptomatic 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 Patients are defined as symptomatic if they meet at least 1 of the following criteria: History 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 Total risk is derived from age, sex, TC, systolic BP and smoking status.
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
Risk categories are: Symptomatic 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 Patients are defined as symptomatic if they meet at least 1 of the following criteria: History 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 Total risk is derived from age, sex, TC, systolic BP and smoking status.
