Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683618

D356FC00007

Details and patient eligibility

About

This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.

Enrollment: 934 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia
• LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L
• Fasting triglyceride less than 4.52mmol/L

Exclusion criteria

• History of statin induced myopathy
• Unstable or uncontrolled cardiovascular diseases
• Familial dysbetalipoproteinemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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934 participants in 3 patient groups

1

Experimental group

Description:

Rosuvastatin 5mg qd

Treatment:

Drug: Rosuvastatin

2

Experimental group

Description:

Rosuvastatin 10mg qd

Treatment:

Drug: Rosuvastatin

3

Active Comparator group

Description:

Atorvastatin 10mg qd

Treatment:

Drug: Atorvastatin