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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654407
First Posted: April 8, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Atorvastatin Drug: Simvastatin Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Percentage change in other cholesterol & triglyceride measures [ Time Frame: 16 weeks ]
  • Safety evaluation [ Time Frame: 8 & 16 weeks ]
  • To compare the efficacy of rosuvastatin with atorvastatin and simvastatin

Estimated Enrollment: 4875
Study Start Date: November 2001
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Atorvastatin
Drug: Atorvastatin
Other Name: Lipitor
Active Comparator: 3
Simvastatin
Drug: Simvastatin
Other Name: Zocor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654407


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joel Raichlen AstraZeneca
Study Director: Russell Esterline AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654407     History of Changes
Other Study ID Numbers: 4522IL/0068
D3560C00068
First Submitted: April 3, 2008
First Posted: April 8, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Cholesterol
hypercholesterolemia
Coronary Heart disease
low density lipoproteins
Rosuvastatin
Atorvastatin
simvastatin

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Simvastatin
Hypolipidemic Agents
Anticholesteremic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors