Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

January 25, 2010 updated by: Kowa Research Europe

Open-Label, Long-Term (1 Year) Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Study Type

Interventional

Enrollment (Actual)

1355

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, 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
      • Hyderabad, India
        • Apollo Hospitals
      • Hyderabad, India
        • CARE Group of Hospitals
      • 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, 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, Rambal 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
      • 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
        • 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 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
      • 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 Depar
      • 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
        • 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
      • Saint Petersburg, Russian Federation
        • St.Petersburg State Medical Institution “Pokrovskaya City Hospitalâ€�, Cardiology Department #2
  • 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
      • Cordoba, Spain
        • Hospital Universitario Reina Sofía
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28000
        • Hospital Ramón 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
        • Hospital de Sagunto
      • 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:

  • Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
  • Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
  • Patients who have been following a fat and cholesterol restrictive diet.

Exclusion Criteria:

  • Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
  • Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
  • Abnormal pancreatic, liver, or renal function
  • Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg 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)
Time Frame: Baseline to 52 Weeks
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Baseline to 52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Cholesterol
Time Frame: Baseline to 52 weeks
Mean percent change from baseline in total cholesterol
Baseline to 52 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., 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

July 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-307
  • 2005-001112-41

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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