Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
- Registration Number
- NCT00325780
- Lead Sponsor
- Kowa Research Europe
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1355
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pitavastatin 4 mg QD Pitavastatin Pitavastatin 4 mg once daily
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Baseline to 52 Weeks Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total Cholesterol Baseline to 52 weeks Mean percent change from baseline in total cholesterol
Trial Locations
- Locations (186)
Medical Center
🇩🇰Copenhagen, Denmark
City Clinical Hospital 64
🇷🇺Moscow, Russian Federation
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
🇷🇺Moscow, Russian Federation
NZOZ Terapia Optima
🇵🇱Katowice, Poland
Hospital Virgen del Roci-o
🇪🇸Sevilla, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital de San Vicente
🇪🇸Alicante, Spain
Szpital Wolski,im. Dr A. Gostynskiej
🇵🇱Warszawa, Poland
Angelholms Sjukhus, Medicinkliniken
🇸🇪Angelhom, Sweden
Stonehill Medical Center
🇬🇧Bolton, United Kingdom
Box Surgery
🇬🇧Wiltshire, United Kingdom
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Centro de Salud de Ventanielles
🇪🇸Oviedo, Spain
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Sahlgrenska University Hospital, Intermedicin
🇸🇪Gothenburg, Sweden
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, Russian Federation
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hjartmottagningen
🇸🇪Helsingborg, Sweden
St Michael's Partnership
🇬🇧Bath, United Kingdom
Hospital Clinico Lozano Blesa
🇪🇸Zaragoza, Spain
Narsjukhuset Sandviken, Kardiologlab, Medicin
🇸🇪Sandviken, Sweden
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Greenwood Medical Center
🇬🇧Nottingham, United Kingdom
St Helier Hospital
🇬🇧Surrey, United Kingdom
Lakarcentrum Nyponet
🇸🇪Karineholm, Sweden
St James's Surgery
🇬🇧Bath, United Kingdom
The Pulteney Practice
🇬🇧Bath, United Kingdom
Avondale Surgery
🇬🇧Chesterfield, United Kingdom
Vasculair Onderzoek Centrum Hoorn
🇳🇱Hoorn, Netherlands
Lecznica PROSEN SMO
🇵🇱Warszawa, Poland
Kemerovo Cardiology Dispensary
🇷🇺Kemerovo, Russian Federation
City Clinical Hospital 23
🇷🇺Moscow, Russian Federation
Birmingham Clinical Research Centre
🇬🇧Birmingham, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
Reading Clinical Research Centre
🇬🇧Reading, United Kingdom
The Burngreave Surgery
🇬🇧Sheffield, United Kingdom
St Chad's Surgery
🇬🇧Wiltshire, United Kingdom
Huslakaren i Sandviken
🇸🇪Sandviken, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Centro de Especialidades Pedro Gonzalez Bueno
🇪🇸Madrid, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital de Sagunto
🇪🇸Valencia, Spain
PD Hinduja Hospital
🇮🇳Mumbai, India
Y Forskning, Bispebjerg Hospital
🇩🇰Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
🇩🇰Frederiksberg, Denmark
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Kolesterollaboratoriet
🇩🇰Hellerup, Denmark
CCBR A/S
🇩🇰Vejle, Denmark
Geri-Med Oy
🇫🇮Helsinki, Finland
Keravan Laakarikeskus
🇫🇮Helsinki, Finland
SOK-Tyoterveyshuolto
🇫🇮Tampere, Finland
Kardiologische Gemeinschaftspraxis Prof. Reifart
🇩🇪Bad Soden/Taunus, Germany
TYKS University Hospital
🇫🇮Turku, Finland
Praxis Dr. Boenninghoff
🇩🇪Beckum, Germany
Klinische Forschung Berlin Mitte
🇩🇪Berlin, Germany
Pharmakologisches Studienzentum Chemnitz
🇩🇪Chemnitz, Germany
GWT-TUK mbH, Zentrum fur Klinische Studien
🇩🇪Dresden, Germany
Gemeinschaftspraxis am Bahnhof
🇩🇪Berlin-Spandau, Germany
Internistische Diabetische Schwerpunktpraxis Dr.
🇩🇪Frankfurt Am Main, Germany
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
🇩🇪Lampertheim, Germany
ZET-Studien GmbH Leipzig
🇩🇪Leipzig, Germany
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
Gemeinschaftspraxis Dr. Krause, Th. Menke
🇩🇪Goch, Germany
Innere Medizin I/Medizinische Klinik
🇩🇪Heidelberg, Germany
Gemeinschaftspraxis Melcherstaette
🇩🇪Melcherstaette, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪Messkirch, Germany
Intermed Institud fur Klinische Forschung und Arzn
🇩🇪Wiesbaden, Germany
School of Diabetology, Nizam Institute of Medical Sciences
🇮🇳Andhra Pradesh, India
Bhagwan Mahaveer Jain Heart Centre
🇮🇳Bangalore, India
Praxisgemeinschaft im Kleinen Biergrund
🇩🇪Offenbach/M, Germany
Gemeinschaftspraxis Dr. Emden, Frank Drewes
🇩🇪Worpswede, Germany
Heart Care Clinic
🇮🇳Gujarat, India
Apollo Hospitals
🇮🇳Hyderabad, India
Sri Ramachandra Medical College Hospital
🇮🇳Chennai, India
CARE Group of Hospitals
🇮🇳Hyderabad, India
St. John's Medical College Hospital
🇮🇳Karnataka, India
Bathia Hospital
🇮🇳Maharashtra, India
King Edward Medical College & Hospital
🇮🇳Maharashtra, India
LTMMC & General Hospital
🇮🇳Maharashtra, India
Sir J. J. Group of Hospitals
🇮🇳Maharashtra, India
Sir Gagaram Hospital
🇮🇳New Delhi, India
Department of Internal Medicine, Wolfson Medical Center
🇮🇱Holon, Israel
Department of Internal Medicine, Soroka Medical Center
🇮🇱Beersheva, Israel
Center for Research, Hadassah University Hospital
🇮🇱Jerusalem Ein Kerem, Israel
Apollo Hospital
🇮🇳Tamil Nadu, India
Department of Internal Medicine A, Rambal Medical Center
🇮🇱Haifa, Israel
Dipartimento di Medicina Interna DIMI
🇮🇹Genova, Italy
Meir Hospital
🇮🇱Kfar Saba, Israel
Department of Medicine, Hadassah Medical Center
🇮🇱Mount Scopus Jerusalem, Israel
Institute of Metabolic Diseases
🇮🇱Tel Aviv, Israel
Department of Internal Medicine, Rivka Sieff Medical Center
🇮🇱Safed, Israel
Institute of Lipid & Atherosclerosis Research
🇮🇱Tel Hashomer, Israel
Centro di Ricerca Clinica
🇮🇹Chieti, Italy
Gerontologia e Geriatria - Universita degli Studi
🇮🇹Ferrara, Italy
Universita di Modena e Reggio Emilia, Policlinico
🇮🇹Modena, Italy
Dipartimento di Medicina Clinica e Biotecnologia Applicata
🇮🇹Bologna, Italy
Dipartimento di Medicina Clinica e Sperimentale
🇮🇹Napoli, Italy
Medicina Clinica e delle Patologie Emergenti
🇮🇹Palermo, Italy
Azienda Ospedaliero-Universitaria
🇮🇹Trieste, Italy
Andromed Breda
🇳🇱Breda, Netherlands
Dipartimento di Medicina Interna e Scienze Biomediche
🇮🇹Parma, Italy
Andromed Eindhoven
🇳🇱Eindhoven, Netherlands
Bomanshof 8
🇳🇱Eindhoven, Netherlands
Andromed Noord
🇳🇱Groningen, Netherlands
Andromed Leiden
🇳🇱Leiden, Netherlands
Andromed Nijmegen
🇳🇱Nijmegen, Netherlands
Kamerlingh Onnesstraat 16-18
🇳🇱Nijmegen, Netherlands
Andromed Rotterdam
🇳🇱Rotterdam, Netherlands
Reigerstraat 30
🇳🇱Velp, Netherlands
Andromed Oost
🇳🇱Velp, Netherlands
Mathenesserlaan 247
🇳🇱Rotterdam, Netherlands
Rivierenland Tiel
🇳🇱Wp Tiel, Netherlands
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands
Parkdreef 142
🇳🇱Zoetermeer, Netherlands
Radhuset Spesialistsenter
🇳🇴Oslo, Norway
Nyomen Legekontor
🇳🇴Kongsberg, Norway
Podlaski Osrodek Kardiologii
🇵🇱Bialystok, Poland
Instytut Zywnosci i Zywienia
🇵🇱Warszawa, Poland
Rikshospitalet - University Hospital
🇳🇴Oslo, Norway
NZOZ GCP Dobra Praktyka Lekaska
🇵🇱Gruziadz, Poland
Skedsmo Medisinske Senter A.S.
🇳🇴Skedsmokorset, Norway
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, Russian Federation
Medicinkliniken
🇸🇪Ludvika, Sweden
Hjart & Karlcenter
🇸🇪Sodertalje, Sweden
Oldfield Surgery
🇬🇧Bath, United Kingdom
Hjarthuset AB
🇸🇪Varberg, Sweden
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
Brook Lane Surgery
🇬🇧Southampton, United Kingdom
Elm Lane Surgery
🇬🇧Sheffield, United Kingdom
Lovemead Group Practice
🇬🇧Wiltshire, United Kingdom
The Porch Surgery
🇬🇧Wiltshire, United Kingdom
Eastleigh Surgery
🇬🇧Wiltshire, United Kingdom
Bradford Road Medical Center
🇬🇧Wiltshire, United Kingdom
Rowden Medical Partnership
🇬🇧Wiltshire, United Kingdom
The Health Centre
🇬🇧Wiltshire, United Kingdom
The Burns Medical Practice
🇬🇧Yorkshire, United Kingdom
Kaisaniemen Laakariasema
🇫🇮Helsinki, Finland
Gemeinschaftspraxis Drs. Mockesch
🇩🇪Weinheim, Germany
Care Hospital
🇮🇳Andhra Pradesh, India
Internistische Gemeinschaftspraxis
🇩🇪Mainz, Germany
Praxis Dr. Wachter
🇩🇪Mannheim, Germany
Department of Cardiology
🇮🇳Tamil Nadu, India
Damsterdiep 9
🇳🇱Groningen, Netherlands
Spec. Gab. Lek. Internistyczno-Kardiologicznly
🇵🇱Tarnow, Poland
Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
🇷🇺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 Development�, Department of Internal Diseases and Rheumatology based at City Clinica
🇷🇺Moscow, Russian Federation
Lokmanya Hospital
🇮🇳Maharashtra, India
NZOZ Centrum, Poradnia Kardiologiczna
🇵🇱Siedlce, Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
🇵🇱Tychy, Poland
Novosibirsk Reg. Clinical Cardiology Dispensary
🇷🇺Novosibirsk, Russian Federation
Krestovsky Island Medical Institute
🇷🇺Saint Petersburg, Russian Federation
Middellaan 5
🇳🇱Breda, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Sliedrecht, Netherlands
NZOZ Esculap, Przychodnia Lekary Rodzinnych
🇵🇱Losice, Poland
Pokrovskaya City Hospital
🇷🇺Saint Petersburg, Russian Federation
Hospital Clinico S. Juan de Alicante
🇪🇸San Juan, Alicante, Spain
Hospital Clinic i Provincial
🇪🇸Villaroel, Barcelona, Spain
Central Clinical Hospital 1 of RZD
🇷🇺Moscow, Russian Federation
U.O. Malattie Metaboliche e Diabetologia
🇮🇹Treviglio, Italy
Doezastraat 1
🇳🇱Leiden, Netherlands
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
St.Petersburg State Medical Institution “Pokrovskaya City Hospital�, 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 Development�, Chair and Department of Faculty Therapy
🇷🇺Saint Petersburg, Russian Federation
Moscow City Clinical Hospital 68
🇷🇺Moscow, Russian Federation
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, Russian Federation
St. Petersburg State Medical Institution “Out-patient Clinic # 109�
🇷🇺Saint Petersburg, Russian Federation
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, Russian Federation
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, Russian Federation
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, Russian Federation
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, Russian Federation
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, Russian Federation
State Research Center for Preventive Medicine
🇷🇺Moscow, Russian Federation
Ruby Hall Clinic
🇮🇳Maharashtra, India