Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
- Conditions
- Primary HypercholesterolemiaDyslipidemia
- Registration Number
- NCT00249249
- Lead Sponsor
- Kowa Research Europe
- Brief Summary
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.
- Detailed Description
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 830
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12 Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Cholesterol (TC) Baseline to 12 Weeks Percent change in total cholesterol from baseline to Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Baseline to 12 weeks percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
TC:HDL-C Ratio 12 weeks Ratio of mean total cholesterol to mean HDL-C at 12 weeks
Triglycerides (TG) 12 weeks mean triglycerides at 12 weeks
Non-HDL:HDL Ratio 12 weeks Ratio of non-HDL to HDL at 12 weeks
Apolipoprotein B (Apo B) 12 weeks Apolipoprotein B at 12 weeks
Apolipoprotein-A1 (Apo-A1) 12 weeks Apolipoprotein-A1 at 12 weeks
Apo-B:Apo-A1 Ratio 12 weeks Ratio of Apo-B to Apo-A1 at 12 weeks
High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks 12 weeks high sensitivity C-reactive protein (hs-CRP) at 12 weeks
Oxidized LDL at 12 Weeks 12 weeks oxidized low density lipoprotein at 12 weeks
National Cholesterol Education Program [NCEP]LDL-C Target Attainment up to 12 weeks Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)
Trial Locations
- Locations (190)
Rikshospitalet - University Hospital
🇳🇴Oslo, Norway
Skedsmo Medisinske Senter A.S.
🇳🇴Skedsmokorset, Norway
Sir J. J. Group of Hospitals
🇮🇳Maharashtra, India
Sir Gagaram Hospital
🇮🇳New Delhi, India
Nyomen Legekontor
🇳🇴Kongsberg, Norway
NZOZ Esculap, Przychodnia Lekary Rodzinnych
🇵🇱Losice, Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly
🇵🇱Tarnow, Poland
Lecznica PROSEN SMO
🇵🇱Warszawa, Poland
PD Hinduja Hospital
🇮🇳Mumbai, India
Hospital Dr. Peset
🇪🇸Valencia, Spain
Parkdreef 142
🇳🇱Zoetermeer, Netherlands
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
St. John's Medical College Hospital,
🇮🇳Karnataka, India
LTMMC & General Hospital
🇮🇳Maharashtra, India
Lokmanya Hospital
🇮🇳Maharashtra, India
St. John's Medical College Hospital
🇮🇳Karnataka, India
Bathia Hospital
🇮🇳Maharashtra, India
Department of Cardiology
🇮🇳Tamil Nadu, India
Doezastraat 1
🇳🇱Leiden, Netherlands
Mathenesserlaan 247
🇳🇱Rotterdam, Netherlands
Reigerstraat 30
🇳🇱Velp, Netherlands
Rivierenland Tiel
🇳🇱Wp Tiel, Netherlands
Angelholms Sjukhus, Medicinkliniken
🇸🇪Angelhom, Sweden
Medicinkliniken
🇸🇪Ludvika, Sweden
Institute of Lipid & Atherosclerosis Research
🇮🇱Tel Hashomer, Israel
Hospital Clinic i Provincial
🇪🇸Villaroel, Barcelona, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital de San Vicente
🇪🇸Alicante, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
St James's Surgery
🇬🇧Bath, United Kingdom
King Edward Medical College & Hospital
🇮🇳Maharashtra, India
Middellaan 5
🇳🇱Breda, Netherlands
Andromed Eindhoven
🇳🇱Eindhoven, Netherlands
Damsterdiep 9
🇳🇱Groningen, Netherlands
Dipartimento di Medicina Interna DIMI
🇮🇹Genova, Italy
Universita di Modena e Reggio Emilia, Policlinico
🇮🇹Modena, Italy
U.O Malattie Metaboliche e Diabetologia
🇮🇹Treviglio, Italy
Center for Research, Hadassah University Hospital
🇮🇱Jerusalem Ein Kerem, Israel
Institute of Metabolic Diseases
🇮🇱Tel Aviv, Israel
Kemerovo Cardiology Dispensary
🇷🇺Kemerovo, Russian Federation
Consulting and Diagnostic Center 85
🇷🇺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
Bomanshof 8
🇳🇱Eindhoven, Netherlands
Vasculair Onderzoek Centrum Hoorn
🇳🇱Hoorn, Netherlands
Andromed Nijmegen
🇳🇱Nijmegen, Netherlands
Kamerlingh Onnesstraat 16-18
🇳🇱Nijmegen, Netherlands
Centro di Ricerca Clinica
🇮🇹Chieti, Italy
Gerontologia e Geriatria - Universita degli Studi
🇮🇹Ferrara, Italy
City Clinical Hospital 64
🇷🇺Moscow, Russian Federation
Department of Internal Medicine, Rivka Sieff Medical Center
🇮🇱Safed, Israel
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
Department of Internal Medicine, Soroka Medical Center
🇮🇱Beersheva, Israel
Department of Medicine, Hadassah Medical Center
🇮🇱Mount Scopus Jerusalem, Israel
Meir Hospital
🇮🇱Kfar Saba, Israel
Andromed Breda
🇳🇱Breda, Netherlands
Dipartimento di Medicina Clinica e Biotecnologia Applicata
🇮🇹Bologna, Italy
Medicina Clinica e delle Patologie Emergenti
🇮🇹Palermo, Italy
Central Clinical Hospital 1 of RZD
🇷🇺Moscow, Russian Federation
Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management
🇷🇺Moscow, Russian Federation
Andromed Noord
🇳🇱Groningen, Netherlands
Andromed Leiden
🇳🇱Leiden, Netherlands
Dipartimento di Medicina Clinica e Sperimentale
🇮🇹Napoli, Italy
Dipartimento di Medicina Interna e Scienze Biomediche
🇮🇹Parma, Italy
Azienda Ospedaliero-Universitaria
🇮🇹Trieste, Italy
Department of Internal Medicine A, Rambam Medical Center
🇮🇱Haifa, Israel
Department of Internal Medicine, Wolfson Medical Center
🇮🇱Holon, Israel
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
Huslakaren i Sandviken
🇸🇪Sandviken, Sweden
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
St Michael's Partnership
🇬🇧Bath, United Kingdom
Saltash Health Center
🇬🇧Cornwall, United Kingdom
Centro de Salud de Ventanielles
🇪🇸Oviedo, Spain
Hospital Clinico Lozano Blesa
🇪🇸Zaragoza, Spain
Narsjukhuset Sandviken, Kardiologlab, Medicin
🇸🇪Sandviken, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
St Helier Hospital
🇬🇧Surrey, United Kingdom
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
The Pulteney Practice
🇬🇧Bath, United Kingdom
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Sahlgrenska University Hospital, Intermedicin
🇸🇪Gothenburg, Sweden
Birmingham Clinical Research Centre
🇬🇧Birmingham, United Kingdom
Greenwood Medical Center
🇬🇧Nottingham, United Kingdom
Hospital Virgen del Roci-o
🇪🇸Sevilla, Spain
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
Lakarcentrum Nyponet
🇸🇪Karineholm, Sweden
Oldfield Surgery
🇬🇧Bath, United Kingdom
Box Surgery
🇬🇧Wiltshire, United Kingdom
Brook Lane Surgery
🇬🇧Southampton, United Kingdom
Gomersal Lane Surgery
🇬🇧Dronfield, United Kingdom
The Health Centre
🇬🇧Wiltshire, United Kingdom
The Burns Medical Practice
🇬🇧Yorkshire, United Kingdom
Hjart & Karlcenter
🇸🇪Sodertalje, Sweden
Stonehill Medical Center
🇬🇧Bolton, United Kingdom
Avondale Surgery
🇬🇧Chesterfield, United Kingdom
Townhead Research
🇬🇧Irvine, United Kingdom
Elm Lane Surgery
🇬🇧Sheffield, United Kingdom
Rowden Medical Partnership
🇬🇧Wiltshire, United Kingdom
St Chad's Surgery
🇬🇧Wiltshire, United Kingdom
The Porch Surgery
🇬🇧Wiltshire, United Kingdom
Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
🇷🇺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 Dept
🇷🇺Moscow, Russian Federation
Central Medical Unit 122, St. Pb
🇷🇺Saint Petersburg, Russian Federation
State Research Center for Preventive Medicine
🇷🇺Moscow, Russian Federation
Clinical Hospital of Russian Academy of Sciences
🇷🇺Saint Petersburg, Russian Federation
Novosibirsk Reg. Clinical Cardiology Dispensary
🇷🇺Novosibirsk, Russian Federation
Pokrovskaya City Hospital
🇷🇺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, Russian Federation
Radhuset Spesialistsenter
🇳🇴Oslo, Norway
Krestovsky Island Medical Institute
🇷🇺Saint Petersburg, Russian Federation
Crosby Clinical Research Centre
🇬🇧Liverpool, United Kingdom
The Burngreave Surgery
🇬🇧Sheffield, United Kingdom
Reading Clinical Research Centre
🇬🇧Reading, United Kingdom
Eastleigh Surgery
🇬🇧Wiltshire, United Kingdom
Hospital Santa Creu I Sant Pau,
🇪🇸Barcelona, Spain
The Symons Medical Center
🇬🇧Maidenhead, United Kingdom
Bradford Road Medical Center
🇬🇧Wiltshire, United Kingdom
Y Forskning, Bispebjerg Hospital
🇩🇰Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
🇩🇰Frederiksberg, Denmark
CCBR A/S
🇩🇰Vejle, Denmark
Medical Center
🇩🇰Copenhagen, Denmark
Kolesterollaboratoriet
🇩🇰Hellerup, Denmark
Copenhagen University Hospital
🇩🇰Copenhagen, 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
Klinische Forschung Berlin Mitte
🇩🇪Berlin, Germany
Gemeinschaftspraxis am Bahnhof
🇩🇪Berlin-Spandau, Germany
Praxis Dr. Boenninghoff
🇩🇪Beckum, Germany
GWT-TUK mbH, Zentrum fur Klinische Studien
🇩🇪Dresden, Germany
Pharmakologisches Studienzentum Chemnitz
🇩🇪Chemnitz, Germany
Internistische Diabetische Schwerpunktpraxis Dr.
🇩🇪Frankfurt Am Main, Germany
Gemeinschaftspraxis Dr. Krause, Th. Menke
🇩🇪Goch, Germany
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
🇩🇪Lampertheim, Germany
Innere Medizin I/Medizinische Klinik
🇩🇪Heidelberg, Germany
Praxis Dr. Wachter
🇩🇪Mannheim, Germany
ZET-Studien GmbH Leipzig
🇩🇪Leipzig, Germany
Gemeinschaftspraxis Melcherstaette
🇩🇪Melcherstaette, Germany
Apollo Hospital
🇮🇳Tamil Nadu, India
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪Messkirch, Germany
Gemeinschaftspraxis Dr. Emden, Frank Drewes
🇩🇪Worpswede, Germany
Internistische Gemeinschaftspraxis
🇩🇪Mainz, Germany
Gemeinschaftspraxis Drs. Mockesch
🇩🇪Weinheim, Germany
Intermed Institud Fur Klinische Forschung und Arzn
🇩🇪Wiesbaden, Germany
Praxisgemeinschaft im Kleinen Biergrund
🇩🇪Offenbach/M, Germany
Care Hospital
🇮🇳Andhra Pradesh, India
School of Diabetology, Nizam Institute of Medical Sciences
🇮🇳Andhra Pradesh, India
Bhagwan Mahaveer Jain Heart Centre
🇮🇳Bangalore, India
Apollo Hospitals
🇮🇳Hyderabaad, India
Heart Care Clinic
🇮🇳Gujarat, India
CARE Group of Hospitals
🇮🇳Hyderabaad, India
Sri Ramachandra Medical College Hospital
🇮🇳Chennai, India
Andromed Rotterdam
🇳🇱Rotterdam, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Sliedrecht, Netherlands
Andromed Oost
🇳🇱Velp, Netherlands
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands
Volvat Medisinske Senter
🇳🇴Fredrikstad, Norway
Podlaski Osrodek Kardiologii
🇵🇱Bialystok, Poland
NZOZ GCP Dobra Praktyka Lekaska
🇵🇱Gruziadz, Poland
NZOZ Terapia Optima
🇵🇱Katowice, Poland
NZOZ Centrum, Poradnia Kardiologiczna
🇵🇱Siedlce, Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
🇵🇱Tychy, Poland
Instytut Zywnosci i Zywienia
🇵🇱Warszawa, Poland
Szpital Wolski im. Dr A. Gostynskiej
🇵🇱Warszawa, Poland
City Clinical Hospital 23
🇷🇺Moscow, Russian Federation
Federal State Institution Outpatient Clinic 3 of Russian Federation of President’s Management
🇷🇺Moscow, Russian Federation
Moscow City Clinical Hospital 68
🇷🇺Moscow, Russian Federation
St. Petersburg State Medical Institution “Out-patient Clinic # 109�
🇷🇺Saint Petersburg, Russian Federation
St. Petersburg State Medical Institution “Outpatient Clinic # 109�
🇷🇺Saint Petersburg, Russian Federation
St. Petersburg State Medical Institution “Pokrovskaya City Hospital�, Cardiology Department #2
🇷🇺Saint Petersburg, Russian Federation
Hospital Clinico S. Juan de Alicante
🇪🇸San Juan, Alicante, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Centro de Especialidades Pedro Gonzalez Bueno
🇪🇸Madrid, Spain
Chorley Clinical Research Centre
🇬🇧Chorley, United Kingdom
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hjartmottagningen
🇸🇪Helsingborg, Sweden
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Manchester Clinical Research Centre
🇬🇧Manchester, United Kingdom
Hjarthuset AB
🇸🇪Varberg, Sweden
Lovemead Group Practice
🇬🇧Wiltshire, United Kingdom
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
Ruby Hall Clinic
🇮🇳Maharashtra, India