Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00427960
• Date of registration: 25/01/2007
• Primary sponsor: AstraZeneca
• Public title: Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
• Scientific 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
• Date of first enrolment: December 2006
• Target sample size: 55
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00427960
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Rhiannon Rowsell, MD
• Affiliation: AstraZeneca

• Name: Shahid Ali, MD
• Affiliation: Bradford PCT

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypercholesterolaemia

Intervention(s)

Behavioral: Dietary advice

Drug: atorvastatin

Drug: rosuvastatin

Primary Outcome(s)

Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) [Time Frame: 6 weeks (baseline) and 12 weeks]

Secondary Outcome(s)

The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1) [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB) [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline (Week 6)in Non-HDL-C [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage Change From Baseline(week6) in TC [Time Frame: 6 weeks (baseline) and 12 weeks]

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. [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category. [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L [Time Frame: 6 weeks (Baseline) and 12 weeks]

The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L [Time Frame: 6 weeks (baseline) and 12 weeks]

The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L [Time Frame: 6 weeks (baseline) and 12 weeks]

Secondary ID(s)

D3560L00060

SHUKRA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors