Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654225

Acronym

IRIS

Enrollment

2340

Registered

2008-04-07

Start date

2002-10-31

Completion date

2005-03-31

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia, Hypercholesterolemia

Keywords

Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, South Asian

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.

Interventions

DRUGRosuvastatin

DRUGAtorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Low density lipoproteins cholesterol levels	6 weeks

Secondary

Measure	Time frame
Safety: adverse events & abnormal laboratory markers	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026