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

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 Overview

• Status: Terminated
• Conditions: Hypercholesterolaemia
• Intervention / Treatment: Behavioral: Dietary advice; Drug: atorvastatin; Drug: rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Allerton, United Kingdom
    • Research Site
  • Birmingham, United Kingdom
    • Research Site
  • Blackburn, United Kingdom
    • Research Site
  • Bolton, United Kingdom
    • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rosuvastatin; rosuvastatin 5 mg	Behavioral: Dietary advice; Drug: rosuvastatin; rosuvastatin 5 mg; Other Names: Crestor
Active Comparator: atorvastatin; atorvastatin 10 mg	Behavioral: Dietary advice; Drug: atorvastatin; atorvastatin 10 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Rhiannon Rowsell, MD, AstraZeneca; Principal Investigator: Shahid Ali, MD, Bradford PCT

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: January 25, 2007
• First Submitted That Met QC Criteria: January 25, 2007
• First Posted (Estimate): January 29, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: cholesterol; Asian; LDL-cholesterol; statin
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: D3560L00060; SHUKRA