Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

NCT ID: NCT00249249

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-11-30

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.

Conditions

Primary Hypercholesterolemia; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pitavastatin

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Research Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Kowa Research Europe, Ltd.

Principal Investigators

Dragos Budinski, Med Dr.

Role: STUDY_DIRECTOR

Kowa Research Europe

Locations

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, , 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

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, , Germany

Apollo Hospital

Andhra Pradesh, , 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

Hyderabaad, , India

CARE Group of Hospitals

Hyderabaad, , India

St. John's Medical College Hospital,

Karnataka, , India

St. John's Medical College Hospital

Karnataka, , India

Bathia Hospital

Maharashtra, , India

LTMMC & General Hospital

Maharashtra, , India

Sir J. J. Group of Hospitals

Maharashtra, , India

King Edward Medical College & Hospital

Maharashtra, , India

Ruby Hall Clinic

Maharashtra, , India

Lokmanya Hospital

Maharashtra, , India

PD Hinduja Hospital

Mumbai, , India

Apollo Hospital

New Delhi, , India

Sir Gagaram Hospital

New Delhi, , India

Apollo Hospital

Tamil Nadu, , India

Department of Cardiology

Tamil Nadu, , India

Department of Internal Medicine, Soroka Medical Center

Beersheva, , Israel

Department of Internal Medicine A, Rambam 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 Litwinsky, , Israel

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, , Italy

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, , Netherlands

Volvat Medisinske Senter

Fredrikstad, , Norway

Nyomen Legekontor

Kongsberg, , Norway

Radhuset Spesialistsenter

Oslo, , Norway

Rikshospitalet - University Hospital

Oslo, , Norway

Skedsmo Medisinske Senter A.S.

Skedsmokorset, , Norway

Podlaski Osrodek Kardiologii

Bialystok, , Poland

NZOZ GCP Dobra Praktyka Lekaska

Gruziadz, , Poland

NZOZ Terapia Optima

Katowice, , Poland

NZOZ Centrum, Poradnia Kardiologiczna

Siedlce, , Poland

Spec. Gab. Lek. Internistyczno-Kardiologicznly

Tarnów, , Poland

Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego

Tychy, , Poland

Instytut Zywnosci i Zywienia

Warsaw, , Poland

Lecznica PROSEN SMO

Warsaw, , Poland

Szpital Wolski im. Dr A. Gostynskiej

Warsaw, , Poland

NZOZ Esculap, Przychodnia Lekary Rodzinnych

Łosice, , Poland

Kemerovo Cardiology Dispensary

Kemerovo, , Russia

Central Clinical Hospital 1 of RZD

Moscow, , Russia

City Clinical Hospital 23

Moscow, , Russia

City Clinical Hospital 64

Moscow, , Russia

Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management

Moscow, , Russia

Federal State Institution Outpatient Clinic 3 of Russian Federation of President’s Management

Moscow, , Russia

Moscow City Clinical Hospital 68

Moscow, , Russia

Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy

Moscow, , Russia

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, , Russia

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, , Russia

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, , Russia

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, , Russia

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, , Russia

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, , Russia

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, , Russia

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, , Russia

State Research Center for Preventive Medicine

Moscow, , Russia

Novosibirsk Reg. Clinical Cardiology Dispensary

Novosibirsk, , Russia

Central Medical Unit 122, St. Pb

Saint Petersburg, , Russia

Clinical Hospital of Russian Academy of Sciences

Saint Petersburg, , Russia

Consulting and Diagnostic Center 85

Saint Petersburg, , Russia

Krestovsky Island Medical Institute

Saint Petersburg, , Russia

Pokrovskaya City Hospital

Saint Petersburg, , Russia

St. Petersburg State Medical Institution “Out-patient Clinic # 109�

Saint Petersburg, , Russia

St. Petersburg State Medical Institution “Outpatient Clinic # 109�

Saint Petersburg, , Russia

St. Petersburg State Medical Institution “Pokrovskaya City Hospital�, Cardiology Department #2

Saint Petersburg, , Russia

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, , Russia

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, , Russia

Hospital Clinico S. Juan de Alicante

San Juan, Alicante, Spain

Hospital Clinic i Provincial

Villaroel, Barcelona, Spain

Hospital de San Vicente

Alicante, , Spain

Hospital Santa Creu I Sant Pau,

Barcelona, , 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

Córdoba, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Centro de Especialidades Pedro Gonzalez Bueno

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Centro de Salud de Ventanielles

Oviedo, , Spain

Hospital Marques de Valdecilla

Santander, , Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Virgen del Roci-o

Seville, , Spain

Hospital Dr. Peset

Valencia, , Spain

Hospital Clinico Lozano Blesa

Zaragoza, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

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

Södertälje, , Sweden

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Hjarthuset AB

Varberg, , Sweden

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, , United Kingdom

Countries

Denmark; Finland; Germany; India; Israel; Italy; Netherlands; Norway; Poland; Russia; Spain; Sweden; United Kingdom

Other Identifiers

EudraCT number 2005-001000-39

Identifier Type: -

Identifier Source: secondary_id

NK-104-301

Identifier Type: -

Identifier Source: org_study_id