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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00654407

Collaborator

(none)

4,875

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Rosuvastatin Drug: Atorvastatin Drug: Simvastatin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4875 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.

Study Start Date :

Nov 1, 2001

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Rosuvastatin	Drug: Rosuvastatin Other Names: Crestor
Active Comparator: 2 Atorvastatin	Drug: Atorvastatin Other Names: Lipitor
Active Comparator: 3 Simvastatin	Drug: Simvastatin Other Names: Zocor

Arm

Intervention/Treatment

Experimental: 1

Rosuvastatin

Drug: Rosuvastatin

Other Names:

Crestor

Active Comparator: 2

Atorvastatin

Drug: Atorvastatin

Other Names:

Lipitor

Active Comparator: 3

Simvastatin

Drug: Simvastatin

Other Names:

Zocor

Outcome Measures

Primary Outcome Measures

Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. [16 weeks]

Secondary Outcome Measures

Percentage change in other cholesterol & triglyceride measures [16 weeks]
Safety evaluation [8 & 16 weeks]
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.