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OpenTrials
Completed

NCT Number: NCT00654407

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

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.

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

atorvastatin

Drug

Other names: Lipitor

simvastatin

Drug

Other names: Zocor

Primary outcomes

  1. Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.

    Time frame: 16 weeks

Secondary outcomes

  1. Percentage change in other cholesterol & triglyceride measures

    Time frame: 16 weeks

  2. Safety evaluation

    Time frame: 8 & 16 weeks

  3. To compare the efficacy of rosuvastatin with atorvastatin and simvastatin

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Study completion
2004
First posted
Apr 8, 2008
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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