Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654225

Purpose

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.

Condition	Intervention	Phase
Hypercholesterolemia Dyslipidaemia	Drug: Rosuvastatin Drug: Atorvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Week, Randomized,Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]

Estimated Enrollment:	2340
Study Start Date:	October 2002
Study Completion Date:	July 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: Active Comparator Atorvastatin	Drug: Atorvastatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Fasting low density lipoprotein & triglyceride levels as defined by the protocol.
Self described South Asian race
Subjects with coronary heart disease or at high risk of coronary heart disease.

Exclusion Criteria:

The use of lipid lowering drugs or dietary supplements after Visit 1.
Active arterial disease eg Unstable angina, or recent arterial surgery
Blood lipid levels above the limits defined in the protocol.
Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654225

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Dr. Prashkrah Deedwania	Institute for Medical consultation, USA
Study Director:	Russell Esterline	AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522US/0006, D3560L00026
Study First Received:	March 26, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00654225
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by AstraZeneca:

Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin

Crestor
Atorvastatin
Lipitor
South Asian

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 January 16, 2009