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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654407
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654407

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

No publications provided by AstraZeneca

Additional 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
Study First Received: April 3, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada
Mexico: National Institute of Public Health, Health Secretariat

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
Hypolipidemic Agents
Simvastatin
Atorvastatin
Rosuvastatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014