Back to resultsTreatment of Hypercholesterolaemia in South Asian Subjects (IRIS) (IRIS)
Primary Purpose
Hypercholesterolemia, Dyslipidaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, South Asian
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Rosuvastatin
Atorvastatin
Outcomes
Primary Outcome Measures
Low density lipoproteins cholesterol levels
Secondary Outcome Measures
Safety: adverse events & abnormal laboratory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654225
Brief Title
Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidaemia
Keywords
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, South Asian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Primary Outcome Measure Information:
Title
Low density lipoproteins cholesterol levels
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety: adverse events & abnormal laboratory markers
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Prashkrah Deedwania
Organizational Affiliation
Institute for Medical consultation, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)
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