Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

Hypercholesterolemia Clinical Trial

— IRIS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654225
• Other study ID #: 4522US/0006
• Secondary ID: D3560L00026
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: March 13, 2009
• Start date: October 2002
• Est. completion date: March 2005

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2340
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density lipoproteins cholesterol levels		6 weeks
Secondary	Safety: adverse events & abnormal laboratory markers		6 weeks