Clinical trial NCT00249249: Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Official title: Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Dyslipidemia
Keywords: hypercholesterolemia
dyslipidemia
kowa
KRE
pitavastatin
NK-104
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2005-11-07
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Total Cholesterol (TC)
timeFrame: Baseline to 12 Weeks
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline to 12 weeks
measure: TC:HDL-C Ratio
timeFrame: 12 weeks
measure: Triglycerides (TG)
timeFrame: 12 weeks
measure: Non-HDL:HDL Ratio
timeFrame: 12 weeks
measure: Apolipoprotein B (Apo B)
timeFrame: 12 weeks
measure: Apolipoprotein-A1 (Apo-A1)
timeFrame: 12 weeks
measure: Apo-B:Apo-A1 Ratio
timeFrame: 12 weeks
measure: High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks
timeFrame: 12 weeks
measure: Oxidized LDL at 12 Weeks
timeFrame: 12 weeks
measure: National Cholesterol Education Program [NCEP]LDL-C Target Attainment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Copenhagen Nv
country: Denmark
facility: Y Forskning, Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Copenhagen
country: Denmark
facility: Medical Center
city: Frederiksberg
country: Denmark
facility: Frederiks Hospital, Kardiologisk
city: Hellerup
country: Denmark
facility: Kolesterollaboratoriet
city: Vejle
country: Denmark
facility: CCBR A/S
city: Helsinki
country: Finland
facility: Geri-Med Oy
city: Helsinki
country: Finland
facility: Kaisaniemen Laakariasema
city: Helsinki
country: Finland
facility: keravan Laakarikeskus
city: Tampere
country: Finland
facility: SOK-tyoterveyshuolto
city: Turku
country: Finland
facility: TYKS University Hospital
city: Bad Soden/Taunus
country: Germany
facility: Kardiologische Gemeinschaftspraxis Prof. Reifart
city: Beckum
country: Germany
facility: Praxis Dr. Boenninghoff
city: Berlin-Spandau
country: Germany
facility: Gemeinschaftspraxis am Bahnhof
city: Berlin
country: Germany
facility: Klinische Forschung Berlin Mitte
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentum Chemnitz
city: Dresden
country: Germany
facility: GWT-TUK mbH, Zentrum fur Klinische Studien
city: Frankfurt Am Main
country: Germany
facility: Internistische Diabetische Schwerpunktpraxis Dr.
city: Goch
country: Germany
facility: Gemeinschaftspraxis Dr. Krause, Th. Menke
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Heidelberg
country: Germany
facility: Innere Medizin I/Medizinische Klinik
city: Lampertheim
country: Germany
facility: Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
city: Leipzig
country: Germany
facility: ZET-Studien GmbH Leipzig
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Mannheim
country: Germany
facility: Praxis Dr. Wachter
city: Melcherstaette
country: Germany
facility: Gemeinschaftspraxis Melcherstaette
city: Messkirch
country: Germany
facility: Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
city: Offenbach/M
country: Germany
facility: Praxisgemeinschaft im Kleinen Biergrund
city: Weinheim
country: Germany
facility: Gemeinschaftspraxis Drs. Mockesch
city: Wiesbaden
country: Germany
facility: Intermed Institud Fur Klinische Forschung und Arzn
city: Worpswede
country: Germany
facility: Gemeinschaftspraxis Dr. Emden, Frank Drewes
city: Andhra Pradesh
country: India
facility: Apollo Hospital
city: Andhra Pradesh
country: India
facility: Care Hospital
city: Andhra Pradesh
country: India
facility: School of Diabetology, Nizam Institute of Medical Sciences
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Heart Centre
city: Chennai
country: India
facility: Sri Ramachandra Medical College Hospital
city: Gujarat
country: India
facility: Heart Care Clinic
city: Hyderabaad
country: India
facility: Apollo Hospitals
city: Hyderabaad
country: India
facility: CARE Group of Hospitals
city: Karnataka
country: India
facility: St. John's Medical College Hospital,
city: Karnataka
country: India
facility: St. John's Medical College Hospital
city: Maharashtra
country: India
facility: Bathia Hospital
city: Maharashtra
country: India
facility: LTMMC & General Hospital
city: Maharashtra
country: India
facility: Sir J. J. Group of Hospitals
city: Maharashtra
country: India
facility: King Edward Medical College & Hospital
city: Maharashtra
country: India
facility: Ruby Hall Clinic
city: Maharashtra
country: India
facility: Lokmanya Hospital
city: Mumbai
country: India
facility: PD Hinduja Hospital
city: New Delhi
country: India
facility: Apollo Hospital
city: New Delhi
country: India
facility: Sir Gagaram Hospital
city: Tamil Nadu
country: India
facility: Apollo Hospital
city: Tamil Nadu
country: India
facility: Department of Cardiology
city: Beersheva
country: Israel
facility: Department of Internal Medicine, Soroka Medical Center
city: Haifa
country: Israel
facility: Department of Internal Medicine A, Rambam Medical Center
city: Holon
country: Israel
facility: Department of Internal Medicine, Wolfson Medical Center
city: Jerusalem Ein Kerem
country: Israel
facility: Center for Research, Hadassah University Hospital
city: Kfar Saba
country: Israel
facility: Meir Hospital
city: Mount Scopus Jerusalem
country: Israel
facility: Department of Medicine, Hadassah Medical Center
city: Safed
country: Israel
facility: Department of Internal Medicine, Rivka Sieff Medical Center
city: Tel Aviv
country: Israel
facility: Institute of Metabolic Diseases
city: Tel Hashomer
country: Israel
facility: Institute of Lipid & Atherosclerosis Research
city: Bologna
country: Italy
facility: Dipartimento di Medicina Clinica e Biotecnologia Applicata
city: Chieti
country: Italy
facility: Centro di Ricerca Clinica
city: Ferrara
country: Italy
facility: Gerontologia e Geriatria - Universita degli Studi
city: Genova
country: Italy
facility: Dipartimento di Medicina Interna DIMI
city: Modena
country: Italy
facility: Universita di Modena e Reggio Emilia, Policlinico
city: Napoli
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale
city: Palermo
country: Italy
facility: Medicina Clinica e delle Patologie Emergenti
city: Parma
country: Italy
facility: Dipartimento di Medicina Interna e Scienze Biomediche
city: Treviglio
country: Italy
facility: U.O Malattie Metaboliche e Diabetologia
city: Trieste
country: Italy
facility: Azienda Ospedaliero-Universitaria
city: Breda
country: Netherlands
facility: Andromed Breda
city: Breda
country: Netherlands
facility: Middellaan 5
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Eindhoven
country: Netherlands
facility: Bomanshof 8
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Groningen
country: Netherlands
facility: Damsterdiep 9
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum Hoorn
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Leiden
country: Netherlands
facility: Doezastraat 1
city: Nijmegen
country: Netherlands
facility: Andromed Nijmegen
city: Nijmegen
country: Netherlands
facility: Kamerlingh Onnesstraat 16-18
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Rotterdam
country: Netherlands
facility: Mathenesserlaan 247
city: Sliedrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Velp
country: Netherlands
facility: Andromed Oost
city: Velp
country: Netherlands
facility: Reigerstraat 30
city: Wp Tiel
country: Netherlands
facility: Rivierenland Tiel
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Zoetermeer
country: Netherlands
facility: Parkdreef 142
city: Fredrikstad
country: Norway
facility: Volvat Medisinske Senter
city: Kongsberg
country: Norway
facility: Nyomen Legekontor
city: Oslo
country: Norway
facility: Radhuset Spesialistsenter
city: Oslo
country: Norway
facility: Rikshospitalet - University Hospital
city: Skedsmokorset
country: Norway
facility: Skedsmo Medisinske Senter A.S.
city: Bialystok
country: Poland
facility: Podlaski Osrodek Kardiologii
city: Gruziadz
country: Poland
facility: NZOZ GCP Dobra Praktyka Lekaska
city: Katowice
country: Poland
facility: NZOZ Terapia Optima
city: Losice
country: Poland
facility: NZOZ Esculap, Przychodnia Lekary Rodzinnych
city: Siedlce
country: Poland
facility: NZOZ Centrum, Poradnia Kardiologiczna
city: Tarnow
country: Poland
facility: Spec. Gab. Lek. Internistyczno-Kardiologicznly
city: Tychy
country: Poland
facility: Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
city: Warszawa
country: Poland
facility: Instytut Zywnosci i Zywienia
city: Warszawa
country: Poland
facility: Lecznica PROSEN SMO
city: Warszawa
country: Poland
facility: Szpital Wolski im. Dr A. Gostynskiej
city: Kemerovo
country: Russian Federation
facility: Kemerovo Cardiology Dispensary
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital 1 of RZD
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 23
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 64
city: Moscow
country: Russian Federation
facility: Federal State Institution Out-Patient Clinic ï€£3 of Russian Federation of Presidentâ€™s Management
city: Moscow
country: Russian Federation
facility: Federal State Institution Outpatient Clinic ï€£3 of Russian Federation of Presidentâ€™s Management
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital 68
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œMoscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Department of Internal Diseases and Rheumatology based at City Clinica
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œMoscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Hospital Therapy Department # 1 based at City Clinical Hospital # 40
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œMoscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Developmentâ€�, Hospital Therapy Department #1 based at City Clinical Hospital # 52
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œRussian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Polyclinic Therapy based at Diagnostic Center # 1
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œRussian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Therapy based at City Hospital # 4
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education â€œRussian State Medical University of Federal Agency of Health Care and Social Developmentâ€�, Department of Hospital Therapy #1 based at City Clinical Hospital #15, Cardiology Dept
city: Moscow
country: Russian Federation
facility: State Institution â€œResearch Institute of Physical and Chemical Medicineâ€� of Federal Agency of Health Care and Social Development, Laboratory of Clinical Cardiology based at Bauman City Hospital # 29
city: Moscow
country: Russian Federation
facility: State Institution â€œRussian Cardiology Research Complexâ€� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis
city: Moscow
country: Russian Federation
facility: State Research Center for Preventive Medicine
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Reg. Clinical Cardiology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Central Medical Unit 122, St. Pb
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital of Russian Academy of Sciences
city: Saint Petersburg
country: Russian Federation
facility: Consulting and Diagnostic Center 85
city: Saint Petersburg
country: Russian Federation
facility: Krestovsky Island Medical Institute
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya City Hospital
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution â€œOut-patient Clinic # 109â€�
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution â€œOutpatient Clinic # 109â€�
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution â€œPokrovskaya City Hospitalâ€�, Cardiology Department #2
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education, â€œSaint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Developmentâ€�, Chair and Department of Faculty Therapy
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education, â€œSaint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Developmentâ€�, Institute of Cardiovascular Diseases
city: San Juan
country: Spain
facility: Hospital Clinico S. Juan de Alicante
state: Alicante
city: Villaroel
country: Spain
facility: Hospital Clinic i Provincial
state: Barcelona
city: Alicante
country: Spain
facility: Hospital de San Vicente
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau,
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Centro de Especialidades Pedro Gonzalez Bueno
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Oviedo
country: Spain
facility: Centro de Salud de Ventanielles
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Roci-o
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Angelhom
country: Sweden
facility: Angelholms Sjukhus, Medicinkliniken
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Intermedicin
city: Helsingborg
country: Sweden
facility: Hjartmottagningen
city: Karineholm
country: Sweden
facility: Lakarcentrum Nyponet
city: Ludvika
country: Sweden
facility: Medicinkliniken
city: Sandviken
country: Sweden
facility: Huslakaren i Sandviken
city: Sandviken
country: Sweden
facility: Narsjukhuset Sandviken, Kardiologlab, Medicin
city: Sodertalje
country: Sweden
facility: Hjart & Karlcenter
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Varberg
country: Sweden
facility: Hjarthuset AB
city: Bath
country: United Kingdom
facility: Oldfield Surgery
city: Bath
country: United Kingdom
facility: St James's Surgery
city: Bath
country: United Kingdom
facility: St Michael's Partnership
city: Bath
country: United Kingdom
facility: The Pulteney Practice
city: Birmingham
country: United Kingdom
facility: Birmingham Clinical Research Centre
city: Bolton
country: United Kingdom
facility: Stonehill Medical Center
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery
city: Chorley
country: United Kingdom
facility: Chorley Clinical Research Centre
city: Cornwall
country: United Kingdom
facility: Saltash Health Center
city: Dronfield
country: United Kingdom
facility: Gomersal Lane Surgery
city: Irvine
country: United Kingdom
facility: Townhead Research
city: Liverpool
country: United Kingdom
facility: Crosby Clinical Research Centre
city: Maidenhead
country: United Kingdom
facility: The Symons Medical Center
city: Manchester
country: United Kingdom
facility: Manchester Clinical Research Centre
city: Nottingham
country: United Kingdom
facility: Greenwood Medical Center
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
city: Reading
country: United Kingdom
facility: Reading Clinical Research Centre
city: Sheffield
country: United Kingdom
facility: Elm Lane Surgery
city: Sheffield
country: United Kingdom
facility: The Burngreave Surgery
city: Southampton
country: United Kingdom
facility: Brook Lane Surgery
city: Surrey
country: United Kingdom
facility: St Helier Hospital
city: Wiltshire
country: United Kingdom
facility: Box Surgery
city: Wiltshire
country: United Kingdom
facility: Bradford Road Medical Center
city: Wiltshire
country: United Kingdom
facility: Eastleigh Surgery
city: Wiltshire
country: United Kingdom
facility: Lovemead Group Practice
city: Wiltshire
country: United Kingdom
facility: Rowden Medical Partnership
city: Wiltshire
country: United Kingdom
facility: St Chad's Surgery
city: Wiltshire
country: United Kingdom
facility: The Health Centre
city: Wiltshire
country: United Kingdom
facility: The Porch Surgery
city: Yorkshire
country: United Kingdom
facility: The Burns Medical Practice
Study officials:
affiliation: Kowa Research Europe
name: Dragos Budinski, Med Dr.
role: STUDY_DIRECTOR
References: