Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

January 7, 2010 updated by: Kowa Research Europe

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

857

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Geri-Med Oy
      • Helsinki, Finland
        • Kaisaniemen Laakariasema
      • Helsinki, Finland
        • Keravan Laakarikeskus
      • Tampere, Finland
        • SOK-Tyoterveyshuolto
      • Turku, Finland
        • TYKS University Hospital
  • Italy
      • Bologna, Italy
        • Dipartimento di Medicina Clinica e Biotecnologia Applicata
      • Chieti, Italy
        • Centro di Ricerca Clinica
      • Ferrara, Italy
        • Gerontologia e Geriatria - Universita degli Studi
      • Genova, Italy
        • Dipartimento di Medicina Interna DIMI
      • Modena, Italy
        • Universita di Modena e Reggio Emilia, Policlinico
      • Napoli, Italy
        • Dipartimento di Medicina Clinica e Sperimentale
      • Palermo, Italy
        • Medicina Clinica e delle Patologie Emergenti
      • Parma, Italy
        • Dipartimento di Medicina Interna e Scienze Biomediche
      • Treviglio, Italy
        • U.O Malattie Metaboliche e Diabetologia
      • Trieste, Italy
        • Azienda Ospedaliero-Universitaria
  • Norway
      • Fredrikstad, Norway
        • Volvat Medisinske Senter
      • Kongsberg, Norway
        • Nyomen Legekontor
      • Oslo, Norway
        • Radhuset Spesialistsenter
      • Oslo, Norway
        • Rikshospitalet - University Hospital
      • Skedsmokorset, Norway
        • Skedsmo Medisinske Senter A.S.
  • Russian Federation
      • Kemerovo, Russian Federation
        • Kemerovo Cardiology Dispensary
      • Moscow, Russian Federation
        • Central Clinical Hospital 1 of RZD
      • Moscow, Russian Federation
        • City Clinical Hospital 23
      • Moscow, Russian Federation
        • City Clinical Hospital 64
      • Moscow, Russian Federation
        • Moscow City Clinical Hospital 68
      • Moscow, Russian Federation
        • State Research Center for Preventive Medicine
      • Novosibirsk, Russian Federation
        • Novosibirsk Reg. Clinical Cardiology Dispensary
      • Saint Petersburg, Russian Federation
        • Central Medical Unit 122, St. Pb
      • Saint Petersburg, Russian Federation
        • Clinical Hospital of Russian Academy of Sciences
      • Saint Petersburg, Russian Federation
        • Consulting and Diagnostic Center 85
      • Saint Petersburg, Russian Federation
        • Krestovsky Island Medical Institute
      • Saint Petersburg, Russian Federation
        • Pokrovskaya City Hospital
  • United Kingdom
      • Bath, United Kingdom
        • St Michael's Partnership
      • Chesterfield, United Kingdom
        • Avondale Surgery
      • Plymouth, United Kingdom
        • Knowle House Surgery
      • Sheffield, United Kingdom
        • The Burngreave Surgery
      • Surrey, United Kingdom
        • St Helier Hospital
      • Wiltshire, United Kingdom
        • Box Surgery
      • Wiltshire, United Kingdom
        • Eastleigh Surgery
      • Wiltshire, United Kingdom
        • Lovemead Group Practice
      • Wiltshire, United Kingdom
        • St Chad's Surgery
      • Wiltshire, United Kingdom
        • The Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin 2 mg
Pitavastatin 2 mg once daily
Drug: Pitavastatin
Pitavastatin once daily
Active Comparator: Simvastatin 20 mg
Simvastatin 20 mg once daily
Drug: Simvastatin
Simvastatin once daily
Experimental: Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin once daily
Active Comparator: Simvastatin 40 mg
Simvastatn 40 mg once daily
Drug: Simvastatin
Simvastatin once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Europe

Investigators

  • Study Director: Dragos Budinski, Med Dr., Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 7, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-302
  • EudraCT number 2005-001033-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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