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

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

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

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

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

Study ID Numbers:	D3560L00060, SHUKRA
First Received:	January 25, 2007
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00427960
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:

Rosuvastatin

Metabolic Diseases

Hyperlipidemias

Metabolic disorder

Hypercholesterolemia

Atorvastatin

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

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