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
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug); Simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Joel Raichlen, Study Director, Affiliation: AstraZeneca Russell Esterline, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
Secondary outcome: Percentage change in other cholesterol & triglyceride measuresSafety evaluation To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: November 2001
Last updated: March 13, 2009
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