NCT00427960

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 22, 2010

Completed
Last Updated

December 16, 2010

Status Verified

November 1, 2010

Enrollment Period

1.2 years

First QC Date

January 25, 2007

Results QC Date

March 25, 2009

Last Update Submit

November 30, 2010

Conditions

Hypercholesterolaemia

Keywords

cholesterolstatinAsianLDL-cholesterol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 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

  • The Percentage Change From Baseline(week6) in TC

    6 weeks (baseline) and 12 weeks

  • The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)

    6 weeks (baseline) and 12 weeks

  • +9 more secondary outcomes

Study Arms (2)

rosuvastatin

ACTIVE COMPARATOR

rosuvastatin 5 mg

Behavioral: Dietary adviceDrug: rosuvastatin

atorvastatin

ACTIVE COMPARATOR

atorvastatin 10 mg

Behavioral: Dietary adviceDrug: atorvastatin

Interventions

Dietary adviceBEHAVIORAL
atorvastatinrosuvastatin
rosuvastatinDRUG

rosuvastatin 5 mg

Also known as: Crestor
rosuvastatin
atorvastatinDRUG

atorvastatin 10 mg

atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self described Asian, first or second generation
  • Male or female \> or = 18 years with primary hypercholesterolaemia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Allerton, United Kingdom

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

Blackburn, United Kingdom

Location

Research Site

Bolton, United Kingdom

Location

Research Site

Crawley, United Kingdom

Location

Research SIte

Glasgow, United Kingdom

Location

Research Site

Newcastle, United Kingdom

Location

Research SIte

Sheffield, United Kingdom

Location

Research SIte

Slough, United Kingdom

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Nutrition AssessmentRosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

The study achieved only 8% of the randomised target number of patients and for this reason alone was terminated early. Planned statistical analyses could not be performed. No scientifically valid conclusions can be drawn from the limited study data.

Results Point of Contact

Title
Gerard Lynch
Organization
Astrazeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Rhiannon Rowsell, MD

    AstraZeneca

    STUDY DIRECTOR

  • Shahid Ali, MD

    Bradford PCT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 16, 2010

Results First Posted

March 22, 2010

Record last verified: 2010-11

Locations

GB(9)