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 - Full Text View

Sponsor:	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:	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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease 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
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

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):

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:	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 February 09, 2012