Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Open-Label, Long-Term (1 Year) Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
2 other identifiers
interventional
1,355
13 countries
186
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
Shorter than P25 for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedFebruary 2, 2010
January 1, 2010
1.3 years
February 10, 2006
August 26, 2009
January 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Baseline to 52 Weeks
Secondary Outcomes (1)
Change From Baseline in Total Cholesterol
Baseline to 52 weeks
Study Arms (1)
Pitavastatin 4 mg QD
EXPERIMENTALPitavastatin 4 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
Copenhagen University Hospital
Copenhagen, Denmark
Medical Center
Copenhagen, Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Kolesterollaboratoriet
Hellerup, Denmark
CCBR A/S
Vejle, Denmark
Geri-Med Oy
Helsinki, Finland
Kaisaniemen Laakariasema
Helsinki, Finland
Keravan Laakarikeskus
Helsinki, Finland
SOK-Tyoterveyshuolto
Tampere, Finland
TYKS University Hospital
Turku, Finland
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden/Taunus, Germany
Praxis Dr. Boenninghoff
Beckum, Germany
Klinische Forschung Berlin Mitte
Berlin, Germany
Gemeinschaftspraxis am Bahnhof
Berlin-Spandau, Germany
Pharmakologisches Studienzentum Chemnitz
Chemnitz, Germany
GWT-TUK mbH, Zentrum fur Klinische Studien
Dresden, Germany
Internistische Diabetische Schwerpunktpraxis Dr.
Frankfurt am Main, Germany
Gemeinschaftspraxis Dr. Krause, Th. Menke
Goch, Germany
Klinische Forschung Hamburg
Hamburg, Germany
Innere Medizin I/Medizinische Klinik
Heidelberg, Germany
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
Lampertheim, Germany
ZET-Studien GmbH Leipzig
Leipzig, Germany
Internistische Gemeinschaftspraxis
Mainz, Germany
Praxis Dr. Wachter
Mannheim, Germany
Gemeinschaftspraxis Melcherstaette
Melcherstaette, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
Messkirch, Germany
Praxisgemeinschaft im Kleinen Biergrund
Offenbach/M, Germany
Gemeinschaftspraxis Drs. Mockesch
Weinheim, Germany
Intermed Institud fur Klinische Forschung und Arzn
Wiesbaden, Germany
Gemeinschaftspraxis Dr. Emden, Frank Drewes
Worpswede, Germany
Care Hospital
Andhra Pradesh, 500034, India
School of Diabetology, Nizam Institute of Medical Sciences
Andhra Pradesh, 500082, India
Bhagwan Mahaveer Jain Heart Centre
Bangalore, India
Sri Ramachandra Medical College Hospital
Chennai, India
Heart Care Clinic
Gujarat, 380054, India
Apollo Hospitals
Hyderabad, India
CARE Group of Hospitals
Hyderabad, India
St. John's Medical College Hospital
Karnataka, 560034, India
Bathia Hospital
Maharashtra, 400007, India
LTMMC & General Hospital
Maharashtra, 400022, India
Sir J. J. Group of Hospitals
Maharashtra, 400027, India
King Edward Medical College & Hospital
Maharashtra, 411001, India
Ruby Hall Clinic
Maharashtra, 411001, India
Lokmanya Hospital
Maharashtra, 411033, India
PD Hinduja Hospital
Mumbai, India
Sir Gagaram Hospital
New Delhi, 110060, India
Apollo Hospital
Tamil Nadu, 600006, India
Department of Cardiology
Tamil Nadu, 641004, India
Department of Internal Medicine, Soroka Medical Center
Beersheva, Israel
Department of Internal Medicine A, Rambal Medical Center
Haifa, Israel
Department of Internal Medicine, Wolfson Medical Center
Holon, Israel
Center for Research, Hadassah University Hospital
Jerusalem Ein Kerem, Israel
Meir Hospital
Kfar Saba, Israel
Department of Medicine, Hadassah Medical Center
Mount Scopus Jerusalem, Israel
Department of Internal Medicine, Rivka Sieff Medical Center
Safed, Israel
Institute of Metabolic Diseases
Tel Aviv, Israel
Institute of Lipid & Atherosclerosis Research
Tel Litwinsky, Israel
Dipartimento di Medicina Clinica e Biotecnologia Applicata
Bologna, Italy
Centro di Ricerca Clinica
Chieti, Italy
Gerontologia e Geriatria - Universita degli Studi
Ferrara, Italy
Dipartimento di Medicina Interna DIMI
Genova, Italy
Universita di Modena e Reggio Emilia, Policlinico
Modena, Italy
Dipartimento di Medicina Clinica e Sperimentale
Napoli, Italy
Medicina Clinica e delle Patologie Emergenti
Palermo, Italy
Dipartimento di Medicina Interna e Scienze Biomediche
Parma, Italy
U.O. Malattie Metaboliche e Diabetologia
Treviglio, Italy
Azienda Ospedaliero-Universitaria
Trieste, Italy
Andromed Breda
Breda, Netherlands
Middellaan 5
Breda, Netherlands
Andromed Eindhoven
Eindhoven, Netherlands
Bomanshof 8
Eindhoven, Netherlands
Andromed Noord
Groningen, Netherlands
Damsterdiep 9
Groningen, Netherlands
Vasculair Onderzoek Centrum Hoorn
Hoorn, Netherlands
Andromed Leiden
Leiden, Netherlands
Doezastraat 1
Leiden, Netherlands
Andromed Nijmegen
Nijmegen, Netherlands
Kamerlingh Onnesstraat 16-18
Nijmegen, Netherlands
Andromed Rotterdam
Rotterdam, Netherlands
Mathenesserlaan 247
Rotterdam, Netherlands
Albert Schweitzer Ziekenhuis
Sliedrecht, Netherlands
Andromed Oost
Velp, Netherlands
Reigerstraat 30
Velp, Netherlands
Rivierenland Tiel
Wp Tiel, Netherlands
Andromed Zoetermeer
Zoetermeer, Netherlands
Parkdreef 142
Zoetermeer, Netherlands
Nyomen Legekontor
Kongsberg, Norway
Radhuset Spesialistsenter
Oslo, Norway
Rikshospitalet - University Hospital
Oslo, Norway
Skedsmo Medisinske Senter A.S.
Skedsmokorset, Norway
Podlaski Osrodek Kardiologii
Bialystok, Poland
NZOZ GCP Dobra Praktyka Lekaska
Gruziadz, Poland
NZOZ Terapia Optima
Katowice, Poland
NZOZ Centrum, Poradnia Kardiologiczna
Siedlce, Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly
Tarnów, Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
Tychy, Poland
Instytut Zywnosci i Zywienia
Warsaw, Poland
Lecznica PROSEN SMO
Warsaw, Poland
Szpital Wolski,im. Dr A. Gostynskiej
Warsaw, Poland
NZOZ Esculap, Przychodnia Lekary Rodzinnych
Łosice, Poland
Kemerovo Cardiology Dispensary
Kemerovo, Russia
Central Clinical Hospital 1 of RZD
Moscow, Russia
City Clinical Hospital 23
Moscow, Russia
City Clinical Hospital 64
Moscow, Russia
Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
Moscow, Russia
Moscow City Clinical Hospital 68
Moscow, Russia
Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
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
Moscow, Russia
State Institution “Russian Cardiology Research Complex� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis
Moscow, Russia
State Research Center for Preventive Medicine
Moscow, Russia
Novosibirsk Reg. Clinical Cardiology Dispensary
Novosibirsk, Russia
Central Medical Unit 122, St. Pb
Saint Petersburg, Russia
Clinical Hospital of Russian Academy of Sciences
Saint Petersburg, Russia
Consulting and Diagnostic Center 85
Saint Petersburg, Russia
Krestovsky Island Medical Institute
Saint Petersburg, Russia
Pokrovskaya City Hospital
Saint Petersburg, Russia
St. Petersburg State Medical Institution “Out-patient Clinic # 109�
Saint Petersburg, Russia
St.Petersburg State Medical Institution “Pokrovskaya City Hospital�, Cardiology Department #2
Saint Petersburg, Russia
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
Saint Petersburg, Russia
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
Saint Petersburg, Russia
Hospital Clinico S. Juan de Alicante
San Juan, Alicante, Spain
Hospital Clinic i Provincial
Villaroel, Barcelona, Spain
Hospital de San Vicente
Alicante, 03690, Spain
Hospital Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Ramon y Cajal
Madrid, 28000, Spain
Centro de Especialidades Pedro Gonzalez Bueno
Madrid, 28037, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Centro de Salud de Ventanielles
Oviedo, 33010, Spain
Hospital Marques de Valdecilla
Santander, 3908, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Hospital Virgen del Roci-o
Seville, 41013, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Hospital de Sagunto
Valencia, Spain
Hospital Clinico Lozano Blesa
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Hjartmottagningen
Helsingborg, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Medicinkliniken
Ludvika, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Hjart & Karlcenter
Södertälje, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Hjarthuset AB
Varberg, Sweden
Oldfield Surgery
Bath, United Kingdom
St James's Surgery
Bath, United Kingdom
St Michael's Partnership
Bath, United Kingdom
The Pulteney Practice
Bath, United Kingdom
Birmingham Clinical Research Centre
Birmingham, United Kingdom
Stonehill Medical Center
Bolton, United Kingdom
Avondale Surgery
Chesterfield, United Kingdom
Chorley Clinical Research Centre
Chorley, United Kingdom
Saltash Health Center
Cornwall, United Kingdom
Gomersal Lane Surgery
Dronfield, United Kingdom
Townhead Research
Irvine, United Kingdom
Crosby Clinical Research Centre
Liverpool, United Kingdom
The Symons Medical Center
Maidenhead, United Kingdom
Manchester Clinical Research Centre
Manchester, United Kingdom
Greenwood Medical Center
Nottingham, United Kingdom
Knowle House Surgery
Plymouth, United Kingdom
Reading Clinical Research Centre
Reading, United Kingdom
Elm Lane Surgery
Sheffield, United Kingdom
The Burngreave Surgery
Sheffield, United Kingdom
Brook Lane Surgery
Southampton, United Kingdom
St Helier Hospital
Surrey, 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
Wiltshire, United Kingdom
The Burns Medical Practice
Yorkshire, United Kingdom
Related Publications (1)
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.
PMID: 20080236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bill Arana
- Organization
- Kowa Research Institute
Study Officials
- STUDY DIRECTOR
Dragos Budinski, Med Dr.
Medical Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 10, 2006
First Posted
May 15, 2006
Study Start
July 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 2, 2010
Results First Posted
January 18, 2010
Record last verified: 2010-01