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

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pitavastatin
Sponsored by
Kowa Research Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Kowa, Hypercholesterolemia, dyslipidemia, pitavastatin, NK-104, Hypercholesterolemia or combined dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Y Forskning, Bispebjerg Hospital
  • Copenhagen University Hospital
  • Medical Center
  • Frederiks Hospital, Kardiologisk
  • Kolesterollaboratoriet
  • CCBR A/S
  • Geri-Med Oy
  • Kaisaniemen Laakariasema
  • Keravan Laakarikeskus
  • SOK-Tyoterveyshuolto
  • TYKS University Hospital
  • Kardiologische Gemeinschaftspraxis Prof. Reifart
  • Praxis Dr. Boenninghoff
  • Gemeinschaftspraxis am Bahnhof
  • Klinische Forschung Berlin Mitte
  • Pharmakologisches Studienzentum Chemnitz
  • GWT-TUK mbH, Zentrum fur Klinische Studien
  • Internistische Diabetische Schwerpunktpraxis Dr.
  • Gemeinschaftspraxis Dr. Krause, Th. Menke
  • Klinische Forschung Hamburg
  • Innere Medizin I/Medizinische Klinik
  • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
  • ZET-Studien GmbH Leipzig
  • Internistische Gemeinschaftspraxis
  • Praxis Dr. Wachter
  • Gemeinschaftspraxis Melcherstaette
  • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
  • Praxisgemeinschaft im Kleinen Biergrund
  • Gemeinschaftspraxis Drs. Mockesch
  • Intermed Institud fur Klinische Forschung und Arzn
  • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • Care Hospital
  • School of Diabetology, Nizam Institute of Medical Sciences
  • Bhagwan Mahaveer Jain Heart Centre
  • Sri Ramachandra Medical College Hospital
  • Heart Care Clinic
  • Apollo Hospitals
  • CARE Group of Hospitals
  • St. John's Medical College Hospital
  • Bathia Hospital
  • LTMMC & General Hospital
  • Sir J. J. Group of Hospitals
  • King Edward Medical College & Hospital
  • Ruby Hall Clinic
  • Lokmanya Hospital
  • PD Hinduja Hospital
  • Sir Gagaram Hospital
  • Apollo Hospital
  • Department of Cardiology
  • Department of Internal Medicine, Soroka Medical Center
  • Department of Internal Medicine A, Rambal Medical Center
  • Department of Internal Medicine, Wolfson Medical Center
  • Center for Research, Hadassah University Hospital
  • Meir Hospital
  • Department of Medicine, Hadassah Medical Center
  • Department of Internal Medicine, Rivka Sieff Medical Center
  • Institute of Metabolic Diseases
  • Institute of Lipid & Atherosclerosis Research
  • Dipartimento di Medicina Clinica e Biotecnologia Applicata
  • Centro di Ricerca Clinica
  • Gerontologia e Geriatria - Universita degli Studi
  • Dipartimento di Medicina Interna DIMI
  • Universita di Modena e Reggio Emilia, Policlinico
  • Dipartimento di Medicina Clinica e Sperimentale
  • Medicina Clinica e delle Patologie Emergenti
  • Dipartimento di Medicina Interna e Scienze Biomediche
  • U.O. Malattie Metaboliche e Diabetologia
  • Azienda Ospedaliero-Universitaria
  • Andromed Breda
  • Middellaan 5
  • Andromed Eindhoven
  • Bomanshof 8
  • Andromed Noord
  • Damsterdiep 9
  • Vasculair Onderzoek Centrum Hoorn
  • Andromed Leiden
  • Doezastraat 1
  • Andromed Nijmegen
  • Kamerlingh Onnesstraat 16-18
  • Andromed Rotterdam
  • Mathenesserlaan 247
  • Albert Schweitzer Ziekenhuis
  • Andromed Oost
  • Reigerstraat 30
  • Rivierenland Tiel
  • Andromed Zoetermeer
  • Parkdreef 142
  • Nyomen Legekontor
  • Radhuset Spesialistsenter
  • Rikshospitalet - University Hospital
  • Skedsmo Medisinske Senter A.S.
  • Podlaski Osrodek Kardiologii
  • NZOZ GCP Dobra Praktyka Lekaska
  • NZOZ Terapia Optima
  • NZOZ Esculap, Przychodnia Lekary Rodzinnych
  • NZOZ Centrum, Poradnia Kardiologiczna
  • Spec. Gab. Lek. Internistyczno-Kardiologicznly
  • Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
  • Instytut Zywnosci i Zywienia
  • Lecznica PROSEN SMO
  • Szpital Wolski,im. Dr A. Gostynskiej
  • Kemerovo Cardiology Dispensary
  • Central Clinical Hospital 1 of RZD
  • City Clinical Hospital 23
  • City Clinical Hospital 64
  • Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
  • Moscow City Clinical Hospital 68
  • Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • State Institution “Russian Cardiology Research Complexâ€� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis
  • State Research Center for Preventive Medicine
  • Novosibirsk Reg. Clinical Cardiology Dispensary
  • Central Medical Unit 122, St. Pb
  • Clinical Hospital of Russian Academy of Sciences
  • Consulting and Diagnostic Center 85
  • Krestovsky Island Medical Institute
  • Pokrovskaya City Hospital
  • St. Petersburg State Medical Institution “Out-patient Clinic # 109â€�
  • St.Petersburg State Medical Institution “Pokrovskaya City Hospitalâ€�, Cardiology Department #2
  • 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
  • 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
  • Hospital Clinico S. Juan de Alicante
  • Hospital Clinic i Provincial
  • Hospital de San Vicente
  • Hospital Santa Creu I Sant Pau
  • Hospital Universitario de Bellvitge
  • Hospital Vall d'Hebron
  • Hospital Universitario Reina Sofia
  • Hospital Ramon y Cajal
  • Centro de Especialidades Pedro Gonzalez Bueno
  • Fundacion Jimenez Diaz
  • Hospital Clinico San Carlos
  • Centro de Salud de Ventanielles
  • Hospital Marques de Valdecilla
  • Hospital Clinico Universitario de Santiago
  • Hospital Virgen del Roci-o
  • Hospital Dr. Peset
  • Hospital de Sagunto
  • Hospital Clinico Lozano Blesa
  • Hospital Miguel Servet
  • Angelholms Sjukhus, Medicinkliniken
  • Sahlgrenska University Hospital, Intermedicin
  • Hjartmottagningen
  • Lakarcentrum Nyponet
  • Medicinkliniken
  • Huslakaren i Sandviken
  • Narsjukhuset Sandviken, Kardiologlab, Medicin
  • Hjart & Karlcenter
  • Karolinska Universitetssjukhuset
  • Hjarthuset AB
  • Oldfield Surgery
  • St James's Surgery
  • St Michael's Partnership
  • The Pulteney Practice
  • Birmingham Clinical Research Centre
  • Stonehill Medical Center
  • Avondale Surgery
  • Chorley Clinical Research Centre
  • Saltash Health Center
  • Gomersal Lane Surgery
  • Townhead Research
  • Crosby Clinical Research Centre
  • The Symons Medical Center
  • Manchester Clinical Research Centre
  • Greenwood Medical Center
  • Knowle House Surgery
  • Reading Clinical Research Centre
  • Elm Lane Surgery
  • The Burngreave Surgery
  • Brook Lane Surgery
  • St Helier Hospital
  • Box Surgery
  • Bradford Road Medical Center
  • Eastleigh Surgery
  • Lovemead Group Practice
  • Rowden Medical Partnership
  • St Chad's Surgery
  • The Health Centre
  • The Porch Surgery
  • The Burns Medical Practice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pitavastatin 4 mg QD

Arm Description

Pitavastatin 4 mg once daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Change From Baseline in Total Cholesterol
Mean percent change from baseline in total cholesterol

Full Information

First Posted
February 10, 2006
Last Updated
January 25, 2010
Sponsor
Kowa Research Europe
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1. Study Identification

Unique Protocol Identification Number
NCT00325780
Brief Title
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Official Title
Open-Label, Long-Term (1 Year) Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
Kowa, Hypercholesterolemia, dyslipidemia, pitavastatin, NK-104, Hypercholesterolemia or combined dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg QD
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin 4 mg once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Description
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time Frame
Baseline to 52 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Cholesterol
Description
Mean percent change from baseline in total cholesterol
Time Frame
Baseline to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, Med Dr.
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Y Forskning, Bispebjerg Hospital
City
Copenhagen Nv
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Medical Center
City
Copenhagen
Country
Denmark
Facility Name
Frederiks Hospital, Kardiologisk
City
Frederiksberg
Country
Denmark
Facility Name
Kolesterollaboratoriet
City
Hellerup
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
Country
Denmark
Facility Name
Geri-Med Oy
City
Helsinki
Country
Finland
Facility Name
Kaisaniemen Laakariasema
City
Helsinki
Country
Finland
Facility Name
Keravan Laakarikeskus
City
Helsinki
Country
Finland
Facility Name
SOK-Tyoterveyshuolto
City
Tampere
Country
Finland
Facility Name
TYKS University Hospital
City
Turku
Country
Finland
Facility Name
Kardiologische Gemeinschaftspraxis Prof. Reifart
City
Bad Soden/Taunus
Country
Germany
Facility Name
Praxis Dr. Boenninghoff
City
Beckum
Country
Germany
Facility Name
Gemeinschaftspraxis am Bahnhof
City
Berlin-Spandau
Country
Germany
Facility Name
Klinische Forschung Berlin Mitte
City
Berlin
Country
Germany
Facility Name
Pharmakologisches Studienzentum Chemnitz
City
Chemnitz
Country
Germany
Facility Name
GWT-TUK mbH, Zentrum fur Klinische Studien
City
Dresden
Country
Germany
Facility Name
Internistische Diabetische Schwerpunktpraxis Dr.
City
Frankfurt Am Main
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Krause, Th. Menke
City
Goch
Country
Germany
Facility Name
Klinische Forschung Hamburg
City
Hamburg
Country
Germany
Facility Name
Innere Medizin I/Medizinische Klinik
City
Heidelberg
Country
Germany
Facility Name
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
City
Lampertheim
Country
Germany
Facility Name
ZET-Studien GmbH Leipzig
City
Leipzig
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Mainz
Country
Germany
Facility Name
Praxis Dr. Wachter
City
Mannheim
Country
Germany
Facility Name
Gemeinschaftspraxis Melcherstaette
City
Melcherstaette
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
City
Messkirch
Country
Germany
Facility Name
Praxisgemeinschaft im Kleinen Biergrund
City
Offenbach/M
Country
Germany
Facility Name
Gemeinschaftspraxis Drs. Mockesch
City
Weinheim
Country
Germany
Facility Name
Intermed Institud fur Klinische Forschung und Arzn
City
Wiesbaden
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Emden, Frank Drewes
City
Worpswede
Country
Germany
Facility Name
Care Hospital
City
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
School of Diabetology, Nizam Institute of Medical Sciences
City
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Bhagwan Mahaveer Jain Heart Centre
City
Bangalore
Country
India
Facility Name
Sri Ramachandra Medical College Hospital
City
Chennai
Country
India
Facility Name
Heart Care Clinic
City
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Apollo Hospitals
City
Hyderabad
Country
India
Facility Name
CARE Group of Hospitals
City
Hyderabad
Country
India
Facility Name
St. John's Medical College Hospital
City
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Bathia Hospital
City
Maharashtra
ZIP/Postal Code
400007
Country
India
Facility Name
LTMMC & General Hospital
City
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Sir J. J. Group of Hospitals
City
Maharashtra
ZIP/Postal Code
400027
Country
India
Facility Name
King Edward Medical College & Hospital
City
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Ruby Hall Clinic
City
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Lokmanya Hospital
City
Maharashtra
ZIP/Postal Code
411033
Country
India
Facility Name
PD Hinduja Hospital
City
Mumbai
Country
India
Facility Name
Sir Gagaram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Apollo Hospital
City
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Department of Cardiology
City
Tamil Nadu
ZIP/Postal Code
641004
Country
India
Facility Name
Department of Internal Medicine, Soroka Medical Center
City
Beersheva
Country
Israel
Facility Name
Department of Internal Medicine A, Rambal Medical Center
City
Haifa
Country
Israel
Facility Name
Department of Internal Medicine, Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Center for Research, Hadassah University Hospital
City
Jerusalem Ein Kerem
Country
Israel
Facility Name
Meir Hospital
City
Kfar Saba
Country
Israel
Facility Name
Department of Medicine, Hadassah Medical Center
City
Mount Scopus Jerusalem
Country
Israel
Facility Name
Department of Internal Medicine, Rivka Sieff Medical Center
City
Safed
Country
Israel
Facility Name
Institute of Metabolic Diseases
City
Tel Aviv
Country
Israel
Facility Name
Institute of Lipid & Atherosclerosis Research
City
Tel Hashomer
Country
Israel
Facility Name
Dipartimento di Medicina Clinica e Biotecnologia Applicata
City
Bologna
Country
Italy
Facility Name
Centro di Ricerca Clinica
City
Chieti
Country
Italy
Facility Name
Gerontologia e Geriatria - Universita degli Studi
City
Ferrara
Country
Italy
Facility Name
Dipartimento di Medicina Interna DIMI
City
Genova
Country
Italy
Facility Name
Universita di Modena e Reggio Emilia, Policlinico
City
Modena
Country
Italy
Facility Name
Dipartimento di Medicina Clinica e Sperimentale
City
Napoli
Country
Italy
Facility Name
Medicina Clinica e delle Patologie Emergenti
City
Palermo
Country
Italy
Facility Name
Dipartimento di Medicina Interna e Scienze Biomediche
City
Parma
Country
Italy
Facility Name
U.O. Malattie Metaboliche e Diabetologia
City
Treviglio
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria
City
Trieste
Country
Italy
Facility Name
Andromed Breda
City
Breda
Country
Netherlands
Facility Name
Middellaan 5
City
Breda
Country
Netherlands
Facility Name
Andromed Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Bomanshof 8
City
Eindhoven
Country
Netherlands
Facility Name
Andromed Noord
City
Groningen
Country
Netherlands
Facility Name
Damsterdiep 9
City
Groningen
Country
Netherlands
Facility Name
Vasculair Onderzoek Centrum Hoorn
City
Hoorn
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiden
Country
Netherlands
Facility Name
Doezastraat 1
City
Leiden
Country
Netherlands
Facility Name
Andromed Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Kamerlingh Onnesstraat 16-18
City
Nijmegen
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Mathenesserlaan 247
City
Rotterdam
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Sliedrecht
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
Country
Netherlands
Facility Name
Reigerstraat 30
City
Velp
Country
Netherlands
Facility Name
Rivierenland Tiel
City
Wp Tiel
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Zoetermeer
Country
Netherlands
Facility Name
Parkdreef 142
City
Zoetermeer
Country
Netherlands
Facility Name
Nyomen Legekontor
City
Kongsberg
Country
Norway
Facility Name
Radhuset Spesialistsenter
City
Oslo
Country
Norway
Facility Name
Rikshospitalet - University Hospital
City
Oslo
Country
Norway
Facility Name
Skedsmo Medisinske Senter A.S.
City
Skedsmokorset
Country
Norway
Facility Name
Podlaski Osrodek Kardiologii
City
Bialystok
Country
Poland
Facility Name
NZOZ GCP Dobra Praktyka Lekaska
City
Gruziadz
Country
Poland
Facility Name
NZOZ Terapia Optima
City
Katowice
Country
Poland
Facility Name
NZOZ Esculap, Przychodnia Lekary Rodzinnych
City
Losice
Country
Poland
Facility Name
NZOZ Centrum, Poradnia Kardiologiczna
City
Siedlce
Country
Poland
Facility Name
Spec. Gab. Lek. Internistyczno-Kardiologicznly
City
Tarnow
Country
Poland
Facility Name
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
City
Tychy
Country
Poland
Facility Name
Instytut Zywnosci i Zywienia
City
Warszawa
Country
Poland
Facility Name
Lecznica PROSEN SMO
City
Warszawa
Country
Poland
Facility Name
Szpital Wolski,im. Dr A. Gostynskiej
City
Warszawa
Country
Poland
Facility Name
Kemerovo Cardiology Dispensary
City
Kemerovo
Country
Russian Federation
Facility Name
Central Clinical Hospital 1 of RZD
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital 23
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital 64
City
Moscow
Country
Russian Federation
Facility Name
Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
City
Moscow
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital 68
City
Moscow
Country
Russian Federation
Facility Name
Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Department of Internal Diseases and Rheumatology based at City Clinica
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Hospital Therapy Department # 1 based at City Clinical Hospital # 40
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Hospital Therapy Department #1 based at City Clinical Hospital # 52
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Development�, Department of Polyclinic Therapy based at Diagnostic Center # 1
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Development�, Department of Therapy based at City Hospital # 4
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education “Russian State Medical University of Federal Agency of Health Care and Social Development�, Department of Hospital Therapy #1 based at City Clinical Hospital #15, Cardiology Depar
City
Moscow
Country
Russian Federation
Facility Name
State Institution “Research Institute of Physical and Chemical Medicine� of Federal Agency of Health Care and Social Development, Laboratory of Clinical Cardiology based at Bauman City Hospital # 29
City
Moscow
Country
Russian Federation
Facility Name
State Institution “Russian Cardiology Research Complex� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis
City
Moscow
Country
Russian Federation
Facility Name
State Research Center for Preventive Medicine
City
Moscow
Country
Russian Federation
Facility Name
Novosibirsk Reg. Clinical Cardiology Dispensary
City
Novosibirsk
Country
Russian Federation
Facility Name
Central Medical Unit 122, St. Pb
City
Saint Petersburg
Country
Russian Federation
Facility Name
Clinical Hospital of Russian Academy of Sciences
City
Saint Petersburg
Country
Russian Federation
Facility Name
Consulting and Diagnostic Center 85
City
Saint Petersburg
Country
Russian Federation
Facility Name
Krestovsky Island Medical Institute
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pokrovskaya City Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State Medical Institution “Out-patient Clinic # 109�
City
Saint Petersburg
Country
Russian Federation
Facility Name
St.Petersburg State Medical Institution “Pokrovskaya City Hospital�, Cardiology Department #2
City
Saint Petersburg
Country
Russian Federation
Facility Name
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 Development�, Chair and Department of Faculty Therapy
City
Saint Petersburg
Country
Russian Federation
Facility Name
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 Development�, Institute of Cardiovascular Diseases
City
Saint Petersburg
Country
Russian Federation
Facility Name
Hospital Clinico S. Juan de Alicante
City
San Juan
State/Province
Alicante
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Villaroel
State/Province
Barcelona
Country
Spain
Facility Name
Hospital de San Vicente
City
Alicante
ZIP/Postal Code
03690
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28000
Country
Spain
Facility Name
Centro de Especialidades Pedro Gonzalez Bueno
City
Madrid
ZIP/Postal Code
28037
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Centro de Salud de Ventanielles
City
Oviedo
ZIP/Postal Code
33010
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
ZIP/Postal Code
3908
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Virgen del Roci-o
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital de Sagunto
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Angelholms Sjukhus, Medicinkliniken
City
Angelhom
Country
Sweden
Facility Name
Sahlgrenska University Hospital, Intermedicin
City
Gothenburg
Country
Sweden
Facility Name
Hjartmottagningen
City
Helsingborg
Country
Sweden
Facility Name
Lakarcentrum Nyponet
City
Karineholm
Country
Sweden
Facility Name
Medicinkliniken
City
Ludvika
Country
Sweden
Facility Name
Huslakaren i Sandviken
City
Sandviken
Country
Sweden
Facility Name
Narsjukhuset Sandviken, Kardiologlab, Medicin
City
Sandviken
Country
Sweden
Facility Name
Hjart & Karlcenter
City
Sodertalje
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
Country
Sweden
Facility Name
Hjarthuset AB
City
Varberg
Country
Sweden
Facility Name
Oldfield Surgery
City
Bath
Country
United Kingdom
Facility Name
St James's Surgery
City
Bath
Country
United Kingdom
Facility Name
St Michael's Partnership
City
Bath
Country
United Kingdom
Facility Name
The Pulteney Practice
City
Bath
Country
United Kingdom
Facility Name
Birmingham Clinical Research Centre
City
Birmingham
Country
United Kingdom
Facility Name
Stonehill Medical Center
City
Bolton
Country
United Kingdom
Facility Name
Avondale Surgery
City
Chesterfield
Country
United Kingdom
Facility Name
Chorley Clinical Research Centre
City
Chorley
Country
United Kingdom
Facility Name
Saltash Health Center
City
Cornwall
Country
United Kingdom
Facility Name
Gomersal Lane Surgery
City
Dronfield
Country
United Kingdom
Facility Name
Townhead Research
City
Irvine
Country
United Kingdom
Facility Name
Crosby Clinical Research Centre
City
Liverpool
Country
United Kingdom
Facility Name
The Symons Medical Center
City
Maidenhead
Country
United Kingdom
Facility Name
Manchester Clinical Research Centre
City
Manchester
Country
United Kingdom
Facility Name
Greenwood Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
Country
United Kingdom
Facility Name
Reading Clinical Research Centre
City
Reading
Country
United Kingdom
Facility Name
Elm Lane Surgery
City
Sheffield
Country
United Kingdom
Facility Name
The Burngreave Surgery
City
Sheffield
Country
United Kingdom
Facility Name
Brook Lane Surgery
City
Southampton
Country
United Kingdom
Facility Name
St Helier Hospital
City
Surrey
Country
United Kingdom
Facility Name
Box Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
Bradford Road Medical Center
City
Wiltshire
Country
United Kingdom
Facility Name
Eastleigh Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
Lovemead Group Practice
City
Wiltshire
Country
United Kingdom
Facility Name
Rowden Medical Partnership
City
Wiltshire
Country
United Kingdom
Facility Name
St Chad's Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
The Health Centre
City
Wiltshire
Country
United Kingdom
Facility Name
The Porch Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
The Burns Medical Practice
City
Yorkshire
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20080236
Citation
Ose L, Budinski D, Hounslow N, Arneson V. Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis. 2010 May;210(1):202-8. doi: 10.1016/j.atherosclerosis.2009.12.009. Epub 2009 Dec 11. Erratum In: Atherosclerosis. 2010 Oct;212(2):704.
Results Reference
derived

Learn more about this trial

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

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