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

AstraZeneca

Status and phase: Terminated; Phase 4

Conditions: Hypercholesterolaemia

Treatments: Drug: rosuvastatin; Drug: atorvastatin; Behavioral: Dietary advice

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427960

D3560L00060

SHUKRA

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

rosuvastatin

Active Comparator group

Description:

rosuvastatin 5 mg

Treatment:

Behavioral: Dietary advice

Drug: rosuvastatin

atorvastatin

Active Comparator group

Description:

atorvastatin 10 mg

Treatment:

Behavioral: Dietary advice

Drug: atorvastatin