Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

January 7, 2010 updated by: Kowa Research Europe

Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Study Type

Interventional

Enrollment (Actual)

830

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

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital
      • Copenhagen, Denmark
        • Medical Center
      • Copenhagen Nv, Denmark
        • Y Forskning, Bispebjerg Hospital
      • Frederiksberg, Denmark
        • Frederiks Hospital, Kardiologisk
      • Hellerup, Denmark
        • Kolesterollaboratoriet
      • Vejle, Denmark
        • CCBR A/S
  • Finland
      • Helsinki, Finland
        • Geri-Med Oy
      • Helsinki, Finland
        • Kaisaniemen Laakariasema
      • Helsinki, Finland
        • Keravan Laakarikeskus
      • Tampere, Finland
        • SOK-Tyoterveyshuolto
      • Turku, Finland
        • TYKS University Hospital
  • Germany
      • Bad Soden/Taunus, Germany
        • Kardiologische Gemeinschaftspraxis Prof. Reifart
      • Beckum, Germany
        • Praxis Dr. Boenninghoff
      • Berlin, Germany
        • Klinische Forschung Berlin Mitte
      • Berlin-Spandau, Germany
        • Gemeinschaftspraxis am Bahnhof
      • Chemnitz, Germany
        • Pharmakologisches Studienzentum Chemnitz
      • Dresden, Germany
        • GWT-TUK mbH, Zentrum fur Klinische Studien
      • Frankfurt Am Main, Germany
        • Internistische Diabetische Schwerpunktpraxis Dr.
      • Goch, Germany
        • Gemeinschaftspraxis Dr. Krause, Th. Menke
      • Hamburg, Germany
        • Klinische Forschung Hamburg
      • Heidelberg, Germany
        • Innere Medizin I/Medizinische Klinik
      • Lampertheim, Germany
        • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
      • Leipzig, Germany
        • ZET-Studien GmbH Leipzig
      • Mainz, Germany
        • Internistische Gemeinschaftspraxis
      • Mannheim, Germany
        • Praxis Dr. Wachter
      • Melcherstaette, Germany
        • Gemeinschaftspraxis Melcherstaette
      • Messkirch, Germany
        • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
      • Offenbach/M, Germany
        • Praxisgemeinschaft im Kleinen Biergrund
      • Weinheim, Germany
        • Gemeinschaftspraxis Drs. Mockesch
      • Wiesbaden, Germany
        • Intermed Institud fur Klinische Forschung und Arzn
      • Worpswede, Germany
        • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • India
      • Andhra Pradesh, India, 500033
        • Apollo Hospital
      • Andhra Pradesh, India, 500034
        • Care Hospital
      • Andhra Pradesh, India, 500082
        • School of Diabetology, Nizam Institute of Medical Sciences
      • Bangalore, India
        • Bhagwan Mahaveer Jain Heart Centre
      • Chennai, India
        • Sri Ramachandra Medical College Hospital
      • Gujarat, India, 380054
        • Heart Care Clinic
      • Hyderabaad, India
        • Apollo Hospitals
      • Hyderabaad, India
        • CARE Group of Hospitals
      • Karnataka, India, 560034
        • St. John's Medical College Hospital,
      • Karnataka, India, 560034
        • St. John's Medical College Hospital
      • Maharashtra, India, 400007
        • Bathia Hospital
      • Maharashtra, India, 400022
        • LTMMC & General Hospital
      • Maharashtra, India, 400027
        • Sir J. J. Group of Hospitals
      • Maharashtra, India, 411001
        • King Edward Medical College & Hospital
      • Maharashtra, India, 411001
        • Ruby Hall Clinic
      • Maharashtra, India, 411033
        • Lokmanya Hospital
      • Mumbai, India
        • PD Hinduja Hospital
      • New Delhi, India, 110044
        • Apollo Hospital
      • New Delhi, India, 110060
        • Sir Gagaram Hospital
      • Tamil Nadu, India, 600006
        • Apollo Hospital
      • Tamil Nadu, India, 641004
        • Department of cardiology
  • Israel
      • Beersheva, Israel
        • Department of Internal Medicine, Soroka Medical Center
      • Haifa, Israel
        • Department of Internal Medicine A, Rambam Medical Center
      • Holon, Israel
        • Department of Internal Medicine, Wolfson Medical Center
      • Jerusalem Ein Kerem, Israel
        • Center for Research, Hadassah University Hospital
      • Kfar Saba, Israel
        • Meir Hospital
      • Mount Scopus Jerusalem, Israel
        • Department of Medicine, Hadassah Medical Center
      • Safed, Israel
        • Department of Internal Medicine, Rivka Sieff Medical Center
      • Tel Aviv, Israel
        • Institute of Metabolic Diseases
      • Tel Hashomer, Israel
        • Institute of Lipid & Atherosclerosis Research
  • 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
  • Netherlands
      • Breda, Netherlands
        • Andromed Breda
      • Breda, Netherlands
        • Middellaan 5
      • Eindhoven, Netherlands
        • Andromed Eindhoven
      • Eindhoven, Netherlands
        • Bomanshof 8
      • Groningen, Netherlands
        • Andromed Noord
      • Groningen, Netherlands
        • Damsterdiep 9
      • Hoorn, Netherlands
        • Vasculair Onderzoek Centrum Hoorn
      • Leiden, Netherlands
        • Andromed Leiden
      • Leiden, Netherlands
        • Doezastraat 1
      • Nijmegen, Netherlands
        • Andromed Nijmegen
      • Nijmegen, Netherlands
        • Kamerlingh Onnesstraat 16-18
      • Rotterdam, Netherlands
        • Andromed Rotterdam
      • Rotterdam, Netherlands
        • Mathenesserlaan 247
      • Sliedrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Velp, Netherlands
        • Andromed Oost
      • Velp, Netherlands
        • Reigerstraat 30
      • Wp Tiel, Netherlands
        • Rivierenland Tiel
      • Zoetermeer, Netherlands
        • Andromed Zoetermeer
      • Zoetermeer, Netherlands
        • Parkdreef 142
  • 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.
  • Poland
      • Bialystok, Poland
        • Podlaski Ośrodek Kardiologii
      • Gruziadz, Poland
        • NZOZ GCP Dobra Praktyka Lekaska
      • Katowice, Poland
        • NZOZ Terapia Optima
      • Losice, Poland
        • NZOZ Esculap, Przychodnia Lekary Rodzinnych
      • Siedlce, Poland
        • NZOZ Centrum, Poradnia Kardiologiczna
      • Tarnow, Poland
        • Spec. Gab. Lek. Internistyczno-Kardiologicznly
      • Tychy, Poland
        • Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
      • Warszawa, Poland
        • Instytut Zywnosci i Zywienia
      • Warszawa, Poland
        • Lecznica PROSEN SMO
      • Warszawa, Poland
        • Szpital Wolski im. Dr A. Gostynskiej
  • 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
        • Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
      • Moscow, Russian Federation
        • Federal State Institution Outpatient Clinic 3 of Russian Federation of President’s Management
      • Moscow, Russian Federation
        • Moscow City Clinical Hospital 68
      • Moscow, Russian Federation
        • Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Department of Internal Diseases and Rheumatology based at City Clinica
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Hospital Therapy Department # 1 based at City Clinical Hospital # 40
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Hospital Therapy Department #1 based at City Clinical Hospital # 52
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Polyclinic Therapy based at Diagnostic Center # 1
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Therapy based at City Hospital # 4
      • Moscow, Russian Federation
        • State Educational Institution of Higher Professional Education “Russian State Medical University of Federal Agency of Health Care and Social Developmentâ€�, Department of Hospital Therapy #1 based at City Clinical Hospital #15, Cardiology Dept
      • Moscow, Russian Federation
        • State Institution “Research Institute of Physical and Chemical Medicineâ€� of Federal Agency of Health Care and Social Development, Laboratory of Clinical Cardiology based at Bauman City Hospital # 29
      • Moscow, Russian Federation
        • State Institution “Russian Cardiology Research Complexâ€� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis
      • 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
      • Saint Petersburg, Russian Federation
        • St. Petersburg State Medical Institution “Out-patient Clinic # 109â€�
      • Saint Petersburg, Russian Federation
        • St. Petersburg State Medical Institution “Outpatient Clinic # 109â€�
      • Saint Petersburg, Russian Federation
        • St. Petersburg State Medical Institution “Pokrovskaya City Hospitalâ€�, Cardiology Department #2
      • Saint Petersburg, Russian Federation
        • State Educational Institution of Higher Professional Education, “Saint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Developmentâ€�, Chair and Department of Faculty Therapy
      • Saint Petersburg, Russian Federation
        • State Educational Institution of Higher Professional Education, “Saint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Developmentâ€�, Institute of Cardiovascular Diseases
  • Spain
      • Alicante, Spain, 03690
        • Hospital de San Vicente
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital Santa Creu I Sant Pau,
      • Cordoba, Spain
        • Hospital Universitario Reina Sofia
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28000
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28037
        • Centro de Especialidades Pedro Gonzalez Bueno
      • Oviedo, Spain, 33010
        • Centro de Salud de Ventanielles
      • Santander, Spain, 3908
        • Hospital Marques de Valdecilla
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago
      • Sevilla, Spain, 41013
        • Hospital Virgen del Roci-o
      • Valencia, Spain, 46017
        • Hospital Dr. Peset
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Alicante
      • San Juan, Alicante, Spain
        • Hospital Clinico S. Juan de Alicante
    • Barcelona
      • Villaroel, Barcelona, Spain
        • Hospital Clinic i Provincial
  • Sweden
      • Angelhom, Sweden
        • Angelholms Sjukhus, Medicinkliniken
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital, Intermedicin
      • Helsingborg, Sweden
        • Hjärtmottagningen
      • Karineholm, Sweden
        • Lakarcentrum Nyponet
      • Ludvika, Sweden
        • Medicinkliniken
      • Sandviken, Sweden
        • Huslakaren i Sandviken
      • Sandviken, Sweden
        • Narsjukhuset Sandviken, Kardiologlab, Medicin
      • Sodertalje, Sweden
        • Hjart & Karlcenter
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset
      • Varberg, Sweden
        • Hjarthuset AB
  • United Kingdom
      • Bath, United Kingdom
        • Oldfield Surgery
      • Bath, United Kingdom
        • St James's Surgery
      • Bath, United Kingdom
        • St Michael's Partnership
      • Bath, United Kingdom
        • The Pulteney Practice
      • Birmingham, United Kingdom
        • Birmingham Clinical Research Centre
      • Bolton, United Kingdom
        • Stonehill Medical Center
      • Chesterfield, United Kingdom
        • Avondale Surgery
      • Chorley, United Kingdom
        • Chorley Clinical Research Centre
      • Cornwall, United Kingdom
        • Saltash Health Center
      • Dronfield, United Kingdom
        • Gomersal Lane Surgery
      • Irvine, United Kingdom
        • Townhead Research
      • Liverpool, United Kingdom
        • Crosby Clinical Research Centre
      • Maidenhead, United Kingdom
        • The Symons Medical Center
      • Manchester, United Kingdom
        • Manchester Clinical Research Centre
      • Nottingham, United Kingdom
        • Greenwood Medical Center
      • Plymouth, United Kingdom
        • Knowle House Surgery
      • Reading, United Kingdom
        • Reading Clinical Research Centre
      • Sheffield, United Kingdom
        • Elm Lane Surgery
      • Sheffield, United Kingdom
        • The Burngreave Surgery
      • Southampton, United Kingdom
        • Brook Lane Surgery
      • Surrey, United Kingdom
        • St Helier Hospital
      • Wiltshire, United Kingdom
        • Box Surgery
      • Wiltshire, United Kingdom
        • Bradford Road Medical Center
      • Wiltshire, United Kingdom
        • Eastleigh Surgery
      • Wiltshire, United Kingdom
        • Lovemead Group Practice
      • Wiltshire, United Kingdom
        • Rowden Medical Partnership
      • Wiltshire, United Kingdom
        • St Chad's Surgery
      • Wiltshire, United Kingdom
        • The Health Centre
      • Wiltshire, United Kingdom
        • The Porch Surgery
      • Yorkshire, United Kingdom
        • The Burns Medical Practice

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 (age 18-75 years).
  • Non-pregnant, non-lactating females
  • Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method.
  • Eligible and able to participate and have given informed consent
  • Must have been following a restrictive diet and does not eat or drink grapefruit
  • Diagnosis of primary hypercholesterolemia or combined dyslipidemia
  • Available for every clinic visit, which will occur in the morning.

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia
  • Conditions which may cause secondary dyslipidemia.
  • Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
  • History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
  • Liver injury
  • Impaired renal function
  • Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
  • Serum creatine kinase (CK) >5 x upper limit of the reference range (ULRR).
  • Uncontrolled hypothyroidism
  • Severe acute illness or severe trauma in the last 3 months
  • Major surgery, 3 months prior to Visit 1
  • Significant cardiovascular disease (CVD) prior to randomization
  • Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats per minute at rest.
  • Left ventricular (LV) ejection fraction < 0.25
  • History of symptomatic cerebrovascular disease
  • Conditions at the discretion of the investigator
  • Known HIV infection
  • Poorly controlled or uncontrolled hypertension.
  • Known muscular or neuromuscular disease of any type
  • Neoplastic disease
  • Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
  • Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
  • Current or recent use of supplements known to alter lipid metabolism
  • Hypersensitivity reactions to other HMG-CoA reductase inhibitors
  • Concomitant medication not permitted
  • Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
  • Excessive obesity
  • Regular clinic attendance in the morning impractical
  • Signs of mental dysfunction or other factors likely to limit ability to cooperate

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Cholesterol (TC)
Time Frame: Baseline to 12 Weeks
Percent change in total cholesterol from baseline to Week 12
Baseline to 12 Weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline to 12 weeks
percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Baseline to 12 weeks
TC:HDL-C Ratio
Time Frame: 12 weeks
Ratio of mean total cholesterol to mean HDL-C at 12 weeks
12 weeks
Triglycerides (TG)
Time Frame: 12 weeks
mean triglycerides at 12 weeks
12 weeks
Non-HDL:HDL Ratio
Time Frame: 12 weeks
Ratio of non-HDL to HDL at 12 weeks
12 weeks
Apolipoprotein B (Apo B)
Time Frame: 12 weeks
Apolipoprotein B at 12 weeks
12 weeks
Apolipoprotein-A1 (Apo-A1)
Time Frame: 12 weeks
Apolipoprotein-A1 at 12 weeks
12 weeks
Apo-B:Apo-A1 Ratio
Time Frame: 12 weeks
Ratio of Apo-B to Apo-A1 at 12 weeks
12 weeks
High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks
Time Frame: 12 weeks
high sensitivity C-reactive protein (hs-CRP) at 12 weeks
12 weeks
Oxidized LDL at 12 Weeks
Time Frame: 12 weeks
oxidized low density lipoprotein at 12 weeks
12 weeks
National Cholesterol Education Program [NCEP]LDL-C Target Attainment
Time Frame: up to 12 weeks
Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)
up to 12 weeks

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., Kowa Research Europe

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

October 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 7, 2005

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-104-301
  • EudraCT number 2005-001000-39

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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