Back to resultsMercury 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
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, hypercholesterolemia, Coronary Heart disease, low density lipoproteins, Rosuvastatin, Atorvastatin, simvastatin
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Rosuvastatin
Atorvastatin
Simvastatin
Outcomes
Primary Outcome Measures
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
Secondary Outcome Measures
Percentage change in other cholesterol & triglyceride measures
Safety evaluation
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654407
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol, hypercholesterolemia, Coronary Heart disease, low density lipoproteins, Rosuvastatin, Atorvastatin, simvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4875 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Atorvastatin
Arm Title
3
Arm Type
Active Comparator
Arm Description
Simvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Primary Outcome Measure Information:
Title
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Percentage change in other cholesterol & triglyceride measures
Time Frame
16 weeks
Title
Safety evaluation
Time Frame
8 & 16 weeks
Title
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Raichlen
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18702965
Citation
Ballantyne CM, Raichlen JS, Cain VA. Statin therapy alters the relationship between apolipoprotein B and low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol targets in high-risk patients: the MERCURY II (Measuring Effective Reductions in Cholesterol Using Rosuvastatin) trial. J Am Coll Cardiol. 2008 Aug 19;52(8):626-32. doi: 10.1016/j.jacc.2008.04.052.
Results Reference
derived
Learn more about this trial
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
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