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

This study has been terminated.
(Due to inadequate recruitment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00427960
First received: January 25, 2007
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Hypercholesterolaemia
Behavioral: Dietary advice
Drug: rosuvastatin
Drug: atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (Baseline) and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
  • The Percentage Change From Baseline (Week 6)in Non-HDL-C [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 55
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rosuvastatin
rosuvastatin 5 mg
Behavioral: Dietary advice Drug: rosuvastatin
rosuvastatin 5 mg
Other Name: Crestor
Active Comparator: atorvastatin
atorvastatin 10 mg
Behavioral: Dietary advice Drug: atorvastatin
atorvastatin 10 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427960

Locations
United Kingdom
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rhiannon Rowsell, MD AstraZeneca
Principal Investigator: Shahid Ali, MD Bradford PCT
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00427960     History of Changes
Other Study ID Numbers: D3560L00060, SHUKRA
Study First Received: January 25, 2007
Results First Received: March 25, 2009
Last Updated: November 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
cholesterol
statin
Asian
LDL-cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014