Hypercholesterolemia Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 1355 |
| Est. completion date | November 2007 |
| Est. primary completion date | November 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | 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 | |
| Finland | Geri-Med Oy | Helsinki | |
| Finland | Kaisaniemen Laakariasema | Helsinki | |
| Finland | Keravan Laakarikeskus | Helsinki | |
| Finland | SOK-Tyoterveyshuolto | Tampere | |
| Finland | TYKS University Hospital | Turku | |
| Germany | 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 | |
| India | Care Hospital | Andhra Pradesh | |
| India | School of Diabetology, Nizam Institute of Medical Sciences | Andhra Pradesh | |
| India | Bhagwan Mahaveer Jain Heart Centre | Bangalore | |
| India | Sri Ramachandra Medical College Hospital | Chennai | |
| India | Heart Care Clinic | Gujarat | |
| India | Apollo Hospitals | Hyderabad | |
| 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 | Lokmanya Hospital | Maharashtra | |
| India | LTMMC & General Hospital | Maharashtra | |
| India | Ruby Hall Clinic | Maharashtra | |
| India | Sir J. J. Group of Hospitals | Maharashtra | |
| India | PD Hinduja Hospital | Mumbai | |
| India | Sir Gagaram Hospital | New Delhi | |
| India | Apollo Hospital | Tamil Nadu | |
| India | Department of Cardiology | Tamil Nadu | |
| Israel | 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 Hashomer | |
| Italy | 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 | |
| Netherlands | 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 | |
| Norway | Nyomen Legekontor | Kongsberg | |
| Norway | Radhuset Spesialistsenter | Oslo | |
| Norway | Rikshospitalet - University Hospital | Oslo | |
| Norway | Skedsmo Medisinske Senter A.S. | Skedsmokorset | |
| Poland | Podlaski Osrodek Kardiologii | Bialystok | |
| Poland | NZOZ GCP Dobra Praktyka Lekaska | Gruziadz | |
| Poland | NZOZ Terapia Optima | Katowice | |
| Poland | NZOZ Esculap, Przychodnia Lekary Rodzinnych | Losice | |
| Poland | NZOZ Centrum, Poradnia Kardiologiczna | Siedlce | |
| Poland | Spec. Gab. Lek. Internistyczno-Kardiologicznly | Tarnow | |
| Poland | Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego | Tychy | |
| Poland | Instytut Zywnosci i Zywienia | Warszawa | |
| Poland | Lecznica PROSEN SMO | Warszawa | |
| Poland | Szpital Wolski,im. Dr A. Gostynskiej | Warszawa | |
| Russian Federation | Kemerovo Cardiology Dispensary | Kemerovo | |
| 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 Development�, 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 Development�, 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 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 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 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 | Novosibirsk Reg. Clinical Cardiology Dispensary | Novosibirsk | |
| 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 # 109� | 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 | 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 | |
| Spain | Hospital de San Vicente | Alicante | |
| Spain | Hospital Santa Creu I Sant Pau | Barcelona | |
| Spain | Hospital Universitario de Bellvitge | Barcelona | |
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario Reina Sofia | Cordoba | |
| Spain | Centro de Especialidades Pedro Gonzalez Bueno | Madrid | |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital Ramon y Cajal | Madrid | |
| Spain | Centro de Salud de Ventanielles | Oviedo | |
| Spain | Hospital Clinico S. Juan de Alicante | San Juan | Alicante |
| Spain | Hospital Marques de Valdecilla | Santander | |
| Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | |
| Spain | Hospital Virgen del Roci-o | Sevilla | |
| Spain | Hospital de Sagunto | Valencia | |
| Spain | Hospital Dr. Peset | Valencia | |
| Spain | Hospital Clinic i Provincial | Villaroel | Barcelona |
| Spain | Hospital Clinico Lozano Blesa | Zaragoza | |
| Spain | Hospital Miguel Servet | Zaragoza | |
| Sweden | 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 | Sodertalje | |
| Sweden | Karolinska Universitetssjukhuset | Stockholm | |
| Sweden | Hjarthuset AB | Varberg | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Kowa Research Europe |
Denmark, Finland, Germany, India, Israel, Italy, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline to 52 Weeks | No | |
| Secondary | Change From Baseline in Total Cholesterol | Baseline to 52 weeks | No |
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