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Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654225
First received: March 26, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
Dyslipidaemia
 Drug: Rosuvastatin
Drug: Atorvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 2340
Study Start Date: October 2002
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
 Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Atorvastatin
 Drug: Atorvastatin
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654225

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

No publications provided

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654225     History of Changes
Other Study ID Numbers: 4522US/0006, D3560L00026
Study First Received: March 26, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by AstraZeneca:
Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
 Crestor
Atorvastatin
Lipitor
South Asian

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013