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

Primary Purpose

Hypercholesterolaemia

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary advice
rosuvastatin
atorvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolaemia focused on measuring cholesterol, statin, Asian, LDL-cholesterol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research SIte
  • Research Site
  • Research SIte
  • Research SIte

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rosuvastatin

atorvastatin

Arm Description

rosuvastatin 5 mg

atorvastatin 10 mg

Outcomes

Primary Outcome Measures

Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100

Secondary Outcome Measures

The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L
The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L
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.
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
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
The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L
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
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
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
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
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
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
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
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.

Full Information

First Posted
January 25, 2007
Last Updated
November 30, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00427960
Brief Title
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Due to inadequate recruitment
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia
Keywords
cholesterol, statin, Asian, LDL-cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rosuvastatin
Arm Type
Active Comparator
Arm Description
rosuvastatin 5 mg
Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Description
atorvastatin 10 mg
Intervention Type
Behavioral
Intervention Name(s)
Dietary advice
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
rosuvastatin 5 mg
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
atorvastatin 10 mg
Primary Outcome Measure Information:
Title
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
Description
Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100
Time Frame
6 weeks (baseline) and 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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.
Description
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
Title
The Percentage Change From Baseline(week6) in TC
Description
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
Title
The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)
Description
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
Title
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
Title
The Percentage Change From Baseline (Week 6)in Non-HDL-C
Description
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
Title
The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)
Description
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
Title
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)
Description
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
Title
The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio
Description
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
Title
The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio
Description
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
Title
The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio
Description
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
Title
The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio
Description
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
Title
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhiannon Rowsell, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shahid Ali, MD
Organizational Affiliation
Bradford PCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Allerton
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Blackburn
Country
United Kingdom
Facility Name
Research Site
City
Bolton
Country
United Kingdom
Facility Name
Research Site
City
Crawley
Country
United Kingdom
Facility Name
Research SIte
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research SIte
City
Sheffield
Country
United Kingdom
Facility Name
Research SIte
City
Slough
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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