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OpenTrials
Completed

NCT Number: NCT00309738

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.

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Key information

Conditions

Hypercholesterolemia Dyslipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CCBR A/S, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females (18-75 years of age)
  • At least two cardiovascular disease risk factors
  • Must have been following a restrictive diet
  • Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion criteria

  • Homozygous familial hypercholesterolemia
  • Conditions which may cause secondary dyslipidemia
  • Uncontrolled diabetes mellitus
  • Abnormal pancreatic, liver or renal function
  • Abnormal serum creatine kinase (CK) above the pre-specified level

Treatment and study plan

Pitavastatin

Drug

simvastatin

Drug

Primary outcomes

  1. Percent Change From Baseline in LDL-C

    Time frame: 12 weeks

    Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary outcomes

  1. Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)

    Time frame: 12 weeks

    Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study title

Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 3, 2006
Registry last updated
Mar 16, 2010

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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