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

This study has been terminated.

( Due to inadequate recruitment )

First Received: January 25, 2007 Last Updated: July 29, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00427960

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	Drug: Rosuvastatin Drug: Atorvastatin Behavioral: Dietary advice	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to compare the efficacy of rosuvastatin 5mg with atorvastatin 10mg in reducing LDL cholesterol in Asian subjects with hypercholesterolaemia. (comparing reduction in LDL cholesterol after 6 weeks of treatment)

Secondary Outcome Measures:

% of subjects reaching the current total cholesterol and LDL cholesterol targets (GMS, JBS2 and EAS targets) % change from baseline
% change in lipid and lipid fractions during 6 weeks of treatment
Safety, reporting AE's and abnormal lab values

Estimated Enrollment:	686
Study Start Date:	December 2006

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

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

Locations

United Kingdom
Research Site
BLACKBURN, United Kingdom
Research Site
CRAWLEY, United Kingdom
Research Site
ALLERTON, United Kingdom
Research Site
BIRMINGHAM, United Kingdom
Research SIte
SLOUGH, United Kingdom
Research SIte
GLASGOW, United Kingdom
Research Site
NEWCASTLE, United Kingdom
Research SIte
SHEFFIELD, United Kingdom
Research Site
BOLTON, 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

Study ID Numbers:	D3560L00060, SHUKRA
Study First Received:	January 25, 2007
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00427960 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

cholesterol
statin
Asian
LDL-cholesterol

Study placed in the following topic categories:

Antimetabolites
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009