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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

934 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Rosuvastatin 5mg qd

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Capsule/Tablet, oral, qd, 6 or 12 weeks

2

Rosuvastatin 10mg qd

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Capsule/Tablet, oral, qd, 6 or 12 weeks

3

Atorvastatin 10mg qd

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Capsule/Tablet, 10mg, oral, qd, 6 weeks

Interventions

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Rosuvastatin

Capsule/Tablet, oral, qd, 6 or 12 weeks

Intervention Type DRUG

Atorvastatin

Capsule/Tablet, 10mg, oral, qd, 6 weeks

Intervention Type DRUG

Other Intervention Names

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Crestor Lipitor

Eligibility Criteria

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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