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

Phase 4

Terminated

• Conditions: Hypercholesterolaemia
• Interventions: Behavioral: Dietary advice; Drug: rosuvastatin; Drug: atorvastatin

• Registration Number: NCT00427960
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-29
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-03-25
• Results First Submitted QC: 2010-03-08
• Results First Posted: 2010-03-22
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rosuvastatin	Dietary advice	rosuvastatin 5 mg
atorvastatin	Dietary advice	atorvastatin 10 mg
rosuvastatin	rosuvastatin	rosuvastatin 5 mg
atorvastatin	atorvastatin	atorvastatin 10 mg

Primary Outcome Measures

Name	Time	Method
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)	6 weeks (baseline) and 12 weeks	Calculated as LDL-C at Week 6 - LDL-C at Week 12\] \* 100

Secondary Outcome Measures

Name	Time	Method
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.	6 weeks (baseline) and 12 weeks	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.
The Percentage Change From Baseline(week6) in TC	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
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	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.	6 weeks (baseline) and 12 weeks	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.

Trial Locations

Locations (2)

Research Site; 🇬🇧 Newcastle, United Kingdom

Research SIte; 🇬🇧 Slough, United Kingdom