Clinical trial NCT00427960: Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypercholesterolaemia
Keywords: cholesterol
statin
Asian
LDL-cholesterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
timeFrame: 6 weeks (baseline) and 12 weeks
Secondary outcomes:
measure: The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L
timeFrame: 6 weeks (Baseline) and 12 weeks
measure: The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline(week6) in TC
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6)in Non-HDL-C
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio
timeFrame: 6 weeks (baseline) and 12 weeks
measure: The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.
timeFrame: 6 weeks (baseline) and 12 weeks
Other outcomes:
Locations:
city: Allerton
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackburn
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Crawley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research SIte
city: Newcastle
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research SIte
city: Slough
country: United Kingdom
facility: Research SIte
Study officials:
affiliation: AstraZeneca
name: Rhiannon Rowsell, MD
role: STUDY_DIRECTOR
affiliation: Bradford PCT
name: Shahid Ali, MD
role: PRINCIPAL_INVESTIGATOR
References: