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CompletedNCT00654225IRISUpdated Mar 16, 2009

Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

A Phase 3 interventional study of Rosuvastatin and Atorvastatin in Hypercholesterolemia and Dyslipidaemia, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-16.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,340
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
  • Dyslipidaemia

Keywords

  • Cholesterol
  • low density lipoproteins
  • dyslipidaemia
  • Rosuvastatin
  • Crestor
  • Atorvastatin
  • Lipitor
  • South Asian
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's planned enrollment of 2,340 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,340 participants (estimated)

Study arms

  • Experimental
    1

    Rosuvastatin

    Drug: Rosuvastatin

  • Active comparator
    2

    Atorvastatin

    Drug: Atorvastatin

Interventions

  • DrugRosuvastatin

    Also known as: Crestor

  • DrugAtorvastatin

    Also known as: Lipitor

06

What researchers measure

Primary outcomes

  1. Low density lipoproteins cholesterol levels

    Time frame: 6 weeks

Secondary outcomes

  1. Safety: adverse events & abnormal laboratory markers

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00654225
Lead sponsor
AstraZeneca
First posted
Apr 7, 2008
Start date
Oct 2002
Completion
Mar 2005
Last update
Mar 16, 2009

Study contacts

Dr. Prashkrah Deedwania
principal investigator · Institute for Medical consultation, USA
Russell Esterline
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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