Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidaemia
• Interventions: Drug: Rosuvastatin; Drug: Atorvastatin

• Registration Number: NCT00654225
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2005-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	Rosuvastatin
2	Atorvastatin	Atorvastatin

Primary Outcome Measures

Name	Time	Method
Low density lipoproteins cholesterol levels	6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events & abnormal laboratory markers	6 weeks