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 ^†

December 8, 2005

Last Updated Date

October 23, 2008

Start Date ^†

November 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309738 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Changes from baseline in other lipid and lipoprotein fractions
Safety and tolerability of pitavastatin

Original Secondary Outcome Measures ^†

Changes from baseline in other lipid and lipoprotein fractions
Safety and tolerability of pitavastatin

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 and 2 or More Risk Factors for Coronary Heart Disease

Brief Summary

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.

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 ^†

300

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark, Netherlands, Spain, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309738

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Kowa Research Europe

Collaborators ^††

Investigators ^†

Study Director:

Dragos Budinski, Med Dr.

Medical Director

Information Provided By

Kowa Research Europe

Verification Date

February 2007

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