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Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS) (IRIS)

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ClinicalTrials.gov Identifier: NCT00654225
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 16, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidaemia Drug: Rosuvastatin Drug: Atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2002
Study Completion Date : March 2005

Arm Intervention/treatment
Experimental: 1
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Drug: Atorvastatin
Other Name: Lipitor

Primary Outcome Measures :
  1. Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654225

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

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654225     History of Changes
Other Study ID Numbers: 4522US/0006
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
low density lipoproteins
South Asian

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors