Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolaemia
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug); Dietary advice (Behavioral)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Rhiannon Rowsell, MD, Study Director, Affiliation: AstraZeneca
Shahid Ali, MD, Principal Investigator, Affiliation: Bradford PCT
Summary
The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in
lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian
patients in the UK.
Clinical Details
Official title: A Phase IV, 6-Week, Randomised, Double-Blind, Multicentre, Parallel Group, Comparative Study to Evaluate the Efficacy of Rosuvastatin 5mg and Atorvastatin 10mg in UK Asian Subjects With Primary Hypercholesterolaemia
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary objective of this study is to compare the efficacy of rosuvastatin 5mg with atorvastatin 10mg in reducing LDL cholesterol in Asian subjects with hypercholesterolaemia. (comparing reduction in LDL cholesterol after 6 weeks of treatment)
Secondary outcome: % of subjects reaching the current total cholesterol and LDL cholesterol targets (GMS, JBS2 and EAS targets) % change from baseline% change in lipid and lipid fractions during 6 weeks of treatment Safety, reporting AE's and abnormal lab values
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Self described Asian, first or second generation
- Male or female > or = 18 years with primary hypercholesterolaemia.
Exclusion Criteria:
- Use of cholesterol lowering drugs from visit 1
- Homozygous familial hypercholesterolaemia
- Active arterial disease within 3 months of study entry
- Poorly controlled diabetes
- Uncontrolled hypothyroidism
- Active liver disease
- History of alcoh/drug abuse.
Locations and Contacts
Research Site, BLACKBURN, United Kingdom
Research Site, CRAWLEY, United Kingdom
Research Site, ALLERTON, United Kingdom
Research Site, BIRMINGHAM, United Kingdom
Research Site, BOLTON, United Kingdom
Research SIte, GLASGOW, United Kingdom
Research Site, NEWCASTLE, United Kingdom
Research SIte, SHEFFIELD, United Kingdom
Research SIte, SLOUGH, United Kingdom
Additional Information
Starting date: December 2006
Last updated: December 3, 2007
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