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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Research Site
Allerton, United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Blackburn, United Kingdom
Research Site
Bolton, United Kingdom
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
Calculated as LDL-C at Week 6 - LDL-C at Week 12\] \* 100
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L
Time frame: 6 weeks (Baseline) and 12 weeks
The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L
Time frame: 6 weeks (baseline) and 12 weeks
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.
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.
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline(week6) in TC
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)
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Research Site
Crawley, United Kingdom
Research SIte
Glasgow, United Kingdom
Research Site
Newcastle, United Kingdom
Research SIte
Sheffield, United Kingdom
Research SIte
Slough, United Kingdom
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6)in Non-HDL-C
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio
Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
Time frame: 6 weeks (baseline) and 12 weeks
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.
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.
Time frame: 6 weeks (baseline) and 12 weeks