Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

This study has been completed.

First Received: November 11, 2005 Last Updated: October 23, 2008 History of Changes

Sponsored by:	Kowa Research Europe
Information provided by:	Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00309777

Purpose

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Condition	Intervention	Phase
Hypercholesterolemia Dyslipidemia	Drug: Pitavastatin Drug: Simvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in lipid and lipoprotein measures from baseline
Safety and tolerability

Estimated Enrollment:	800
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309777

Show 42 Study Locations

Sponsors and Collaborators

Kowa Research Europe

Investigators

Study Director:

Dragos Budinski, Med Dr.

Medical Director

More Information

No publications provided

Study ID Numbers:	NK-104-302, EudraCT number 2005-001033-15
Study First Received:	November 11, 2005
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00309777 History of Changes
Health Authority:	Italy: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Finland: Ethics Committee; United Kingdom: National Health Service; Norway: Norwegian Medicines Agency

Keywords provided by Kowa Research Europe:

hypercholesterolemia
kowa
dyslipidemia

pitavastatin
NK-104
Primary Hypercholesterolemia or Combined Dyslipidemia

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
NK 104
Simvastatin
Antilipemic Agents

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
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
NK 104
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009