Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 11, 2005

Last Updated Date

October 23, 2008

Start Date ^†

November 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309777 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Changes in lipid and lipoprotein measures from baseline
Safety and tolerability

Original Secondary Outcome Measures ^†

Changes in lipid and lipoprotein measures from baseline
Safety and tolerability

Descriptive Information

Brief Title ^†

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Official Title ^†

Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hypercholesterolemia
Dyslipidemia

Intervention ^†

Drug: Pitavastatin
Drug: Simvastatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

800

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Finland, Italy, Norway, Russian Federation, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309777

Responsible Party

Secondary IDs ^††

EudraCT number 2005-001033-15

Study Sponsor ^†

Kowa Research Europe

Collaborators ^††

Investigators ^†

Study Director:

Dragos Budinski, Med Dr.

Medical Director

Information Provided By

Kowa Research Europe

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.