Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Primary Hypercholesterolemia, Dyslipidemia
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring hypercholesterolemia, dyslipidemia, kowa, KRE, pitavastatin, NK-104
Eligibility Criteria
Inclusion Criteria: Males and females (age 18-75 years). Non-pregnant, non-lactating females Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method. Eligible and able to participate and have given informed consent Must have been following a restrictive diet and does not eat or drink grapefruit Diagnosis of primary hypercholesterolemia or combined dyslipidemia Available for every clinic visit, which will occur in the morning. Exclusion Criteria: Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia Conditions which may cause secondary dyslipidemia. Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury Liver injury Impaired renal function Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator Serum creatine kinase (CK) >5 x upper limit of the reference range (ULRR). Uncontrolled hypothyroidism Severe acute illness or severe trauma in the last 3 months Major surgery, 3 months prior to Visit 1 Significant cardiovascular disease (CVD) prior to randomization Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats per minute at rest. Left ventricular (LV) ejection fraction < 0.25 History of symptomatic cerebrovascular disease Conditions at the discretion of the investigator Known HIV infection Poorly controlled or uncontrolled hypertension. Known muscular or neuromuscular disease of any type Neoplastic disease Drug abuse or continuous consumption of more than 65 mL pure alcohol per day Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system Current or recent use of supplements known to alter lipid metabolism Hypersensitivity reactions to other HMG-CoA reductase inhibitors Concomitant medication not permitted Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent Excessive obesity Regular clinic attendance in the morning impractical Signs of mental dysfunction or other factors likely to limit ability to cooperate
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
- Apollo Hospital
- 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,
- 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
- Apollo Hospital
- Sir Gagaram Hospital
- Apollo Hospital
- Department of Cardiology
- Department of Internal Medicine, Soroka Medical Center
- Department of Internal Medicine A, Rambam 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
- Volvat Medisinske Senter
- 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
- Federal State Institution Outpatient 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 Development�, 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 Development�, 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 Development�, 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 Development�, 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 Development�, 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 Development�, Department of Hospital Therapy #1 based at City Clinical Hospital #15, Cardiology Dept
- 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
- State Institution “Russian Cardiology Research Complex� 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 # 109�
- St. Petersburg State Medical Institution “Outpatient Clinic # 109�
- St. Petersburg State Medical Institution “Pokrovskaya City Hospital�, 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 Development�, 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 Development�, 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 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 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