Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: Simvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654407

4522IL/0068

D3560C00068

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.

Enrollment: 4,875 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Discontinuation of all cholesterol lowing drugs, including dietary supplements.
• Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

Exclusion criteria

• The use of lipid lowering drugs or dietary supplements after Visit 1.
• Active arterial disease eg Unstable angina, or recent arterial surgery
• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
• Abnormal laboratory parameters as defined in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,875 participants in 3 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

Atorvastatin

Treatment:

Drug: Atorvastatin

3

Active Comparator group

Description:

Simvastatin

Treatment:

Drug: Simvastatin