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
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.
2 other identifiers
interventional
4,875
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2001
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 8, 2008
CompletedMarch 16, 2009
March 1, 2009
April 3, 2008
March 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
16 weeks
Secondary Outcomes (3)
Percentage change in other cholesterol & triglyceride measures
16 weeks
Safety evaluation
8 & 16 weeks
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
Study Arms (3)
1
EXPERIMENTALRosuvastatin
2
ACTIVE COMPARATORAtorvastatin
3
ACTIVE COMPARATORSimvastatin
Interventions
Eligibility Criteria
You may qualify if:
- Discontinuation of all cholesterol lowing drugs, including dietary supplements.
- Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (1)
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.
PMID: 18702965DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joel Raichlen
AstraZeneca
- STUDY DIRECTOR
Russell Esterline
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 8, 2008
Study Start
November 1, 2001
Study Completion
September 1, 2004
Last Updated
March 16, 2009
Record last verified: 2009-03