Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolaemia

Intervention / Treatment
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* Behavioral: Dietary advice
* Drug: rosuvastatin
* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rosuvastatin<br>rosuvastatin 5 mg | Behavioral: Dietary advice<br> <br> Drug: rosuvastatin<br>* rosuvastatin 5 mg<br>* Other names: Crestor;|
| Active Comparator: atorvastatin<br>atorvastatin 10 mg | Behavioral: Dietary advice<br> <br> Drug: atorvastatin<br>* atorvastatin 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) | Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100 | 6 weeks (baseline) and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L |  | 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 |  | 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. | 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 | 6 weeks (baseline) and 12 weeks | 
| The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks | 
| The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L |  | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 6 weeks (baseline) and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, statin, Asian, LDL-cholesterol