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.

First Received: April 3, 2008 Last Updated: March 13, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654407

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Heart Diseases Mercury

Drug Information available for: Lipids Simvastatin Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: Active Comparator Atorvastatin	Drug: Atorvastatin
3: Active Comparator Simvastatin	Drug: Simvastatin

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

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 National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522IL/0068, D3560C00068
Study First Received:	April 3, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00654407 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Coronary Disease
Rosuvastatin
Hypercholesterolemia
Metabolic Disorder
Coronary Artery Disease
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 09, 2009