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.

Completed

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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

Geri-Med Oy, Helsinki, Finland

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)
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion criteria

Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
Conditions which may cause secondary dyslipidemia.
Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
Abnormal serum creatine kinase (CK) above the pre-specified level
Abnormal pancreatic, liver or renal function
Significant heart disease

Treatment and study plan

Pitavastatin

Drug

Pitavastatin once daily

simvastatin

Drug

Simvastatin once daily

Primary outcomes

Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks

Time frame: Baseline to 12 weeks

Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks

Secondary outcomes

National Cholesterol Education Program (NCEP) LDL-C Target Attainment

Time frame: 12 week

Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Apr 3, 2006
Registry last updated: Jan 12, 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.

Published trials that share one or more normalized conditions with this study.

Completed