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

NCT ID: NCT00427960

Last Updated: 2010-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Hypercholesterolaemia

Keywords

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cholesterol statin Asian LDL-cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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rosuvastatin

rosuvastatin 5 mg

Group Type ACTIVE_COMPARATOR

Dietary advice

Intervention Type BEHAVIORAL

rosuvastatin

Intervention Type DRUG

rosuvastatin 5 mg

atorvastatin

atorvastatin 10 mg

Group Type ACTIVE_COMPARATOR

Dietary advice

Intervention Type BEHAVIORAL

atorvastatin

Intervention Type DRUG

atorvastatin 10 mg

Interventions

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Dietary advice

Intervention Type BEHAVIORAL

rosuvastatin

rosuvastatin 5 mg

Intervention Type DRUG

atorvastatin

atorvastatin 10 mg

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Rhiannon Rowsell, MD

Role: STUDY_DIRECTOR

AstraZeneca

Shahid Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Bradford PCT

Locations

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Research Site

Allerton, , United Kingdom

Site Status

Research Site

Birmingham, , United Kingdom

Site Status

Research Site

Blackburn, , United Kingdom

Site Status

Research Site

Bolton, , United Kingdom

Site Status

Research Site

Crawley, , United Kingdom

Site Status

Research SIte

Glasgow, , United Kingdom

Site Status

Research Site

Newcastle, , United Kingdom

Site Status

Research SIte

Sheffield, , United Kingdom

Site Status

Research SIte

Slough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D3560L00060

Identifier Type: -

Identifier Source: org_study_id

SHUKRA

Identifier Type: -

Identifier Source: secondary_id