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Completed

NCT Number: NCT00654225

Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidaemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

atorvastatin

Drug

Other names: Lipitor

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: IRIS

Important dates

Study start
2002
Study completion
2005
First posted
Apr 7, 2008
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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