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Primary HypercholesterolemiaPhase 3NCT00249249

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

A Phase 3 study testing Pitavastatin and Atorvastatin in people with Primary Hypercholesterolemia and Dyslipidemia, run by Kowa Research Europe at 192 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Hypercholesterolemia, Dyslipidemia
What is being tested?
Pitavastatin and Atorvastatin
How many people
830 participants
Where
192 sitesin 13 countries
Study dates
Oct 2005to Nov 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

192 sites in 13 countries.

192 sites in 13 countries

United Kingdom30 sites

  • Oldfield Surgery

    Bath

  • St James's Surgery

    Bath

  • St Michael's Partnership

    Bath

  • The Pulteney Practice

    Bath

  • Birmingham Clinical Research Centre

    Birmingham

  • Stonehill Medical Center

    Bolton

  • Avondale Surgery

    Chesterfield

  • Chorley Clinical Research Centre

    Chorley

  • Saltash Health Center

    Cornwall

  • Gomersal Lane Surgery

    Dronfield

  • Townhead Research

    Irvine

  • Crosby Clinical Research Centre

    Liverpool

  • The Symons Medical Center

    Maidenhead

  • Manchester Clinical Research Centre

    Manchester

  • Greenwood Medical Center

    Nottingham

  • Knowle House Surgery

    Plymouth

  • Reading Clinical Research Centre

    Reading

  • Elm Lane Surgery

    Sheffield

  • The Burngreave Surgery

    Sheffield

  • Brook Lane Surgery

    Southampton

  • St Helier Hospital

    Surrey

  • Box Surgery

    Wiltshire

  • Bradford Road Medical Center

    Wiltshire

  • Eastleigh Surgery

    Wiltshire

  • Lovemead Group Practice

    Wiltshire

  • Rowden Medical Partnership

    Wiltshire

  • St Chad's Surgery

    Wiltshire

  • The Health Centre

    Wiltshire

  • The Porch Surgery

    Wiltshire

  • The Burns Medical Practice

    Yorkshire

Other trials in United Kingdom

Russia28 sites

  • Kemerovo Cardiology Dispensary

    Kemerovo

  • Central Clinical Hospital 1 of RZD

    Moscow

  • City Clinical Hospital 23

    Moscow

  • City Clinical Hospital 64

    Moscow

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

    Moscow

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

    Moscow

  • Moscow City Clinical Hospital 68

    Moscow

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

    Moscow

  • State Educational Institution of Higher Professional Education “Moscow 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

    Moscow

  • State Educational Institution of Higher Professional Education “Moscow 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

    Moscow

  • State Educational Institution of Higher Professional Education “Moscow 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

    Moscow

  • State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Polyclinic Therapy based at Diagnostic Center # 1

    Moscow

  • State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Developmentâ€�, Department of Therapy based at City Hospital # 4

    Moscow

  • State Educational Institution of Higher Professional Education “Russian 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

    Moscow

  • State Institution “Research 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

    Moscow

  • State Institution “Russian Cardiology Research Complexâ€� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis

    Moscow

  • State Research Center for Preventive Medicine

    Moscow

  • Novosibirsk Reg. Clinical Cardiology Dispensary

    Novosibirsk

  • Central Medical Unit 122, St. Pb

    Saint Petersburg

  • Clinical Hospital of Russian Academy of Sciences

    Saint Petersburg

  • Consulting and Diagnostic Center 85

    Saint Petersburg

  • Krestovsky Island Medical Institute

    Saint Petersburg

  • Pokrovskaya City Hospital

    Saint Petersburg

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

    Saint Petersburg

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

    Saint Petersburg

  • St. Petersburg State Medical Institution “Pokrovskaya City Hospitalâ€�, Cardiology Department #2

    Saint Petersburg

  • 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 Developmentâ€�, Chair and Department of Faculty Therapy

    Saint Petersburg

  • 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 Developmentâ€�, Institute of Cardiovascular Diseases

    Saint Petersburg

Other trials in Russia

India21 sites

  • Apollo Hospital

    Andhra Pradesh, 500033

  • Care Hospital

    Andhra Pradesh, 500034

  • School of Diabetology, Nizam Institute of Medical Sciences

    Andhra Pradesh, 500082

  • Bhagwan Mahaveer Jain Heart Centre

    Bangalore

  • Sri Ramachandra Medical College Hospital

    Chennai

  • Heart Care Clinic

    Gujarat, 380054

  • Apollo Hospitals

    Hyderabaad

  • CARE Group of Hospitals

    Hyderabaad

  • St. John's Medical College Hospital,

    Karnataka, 560034

  • St. John's Medical College Hospital

    Karnataka, 560034

  • Bathia Hospital

    Maharashtra, 400007

  • LTMMC & General Hospital

    Maharashtra, 400022

  • Sir J. J. Group of Hospitals

    Maharashtra, 400027

  • King Edward Medical College & Hospital

    Maharashtra, 411001

  • Ruby Hall Clinic

    Maharashtra, 411001

  • Lokmanya Hospital

    Maharashtra, 411033

  • PD Hinduja Hospital

    Mumbai

  • Apollo Hospital

    New Delhi, 110044

  • Sir Gagaram Hospital

    New Delhi, 110060

  • Apollo Hospital

    Tamil Nadu, 600006

  • Department of Cardiology

    Tamil Nadu, 641004

Other trials in India

Germany20 sites

  • Kardiologische Gemeinschaftspraxis Prof. Reifart

    Bad Soden/Taunus

  • Praxis Dr. Boenninghoff

    Beckum

  • Klinische Forschung Berlin Mitte

    Berlin

  • Gemeinschaftspraxis am Bahnhof

    Berlin-Spandau

  • Pharmakologisches Studienzentum Chemnitz

    Chemnitz

  • GWT-TUK mbH, Zentrum fur Klinische Studien

    Dresden

  • Internistische Diabetische Schwerpunktpraxis Dr.

    Frankfurt am Main

  • Gemeinschaftspraxis Dr. Krause, Th. Menke

    Goch

  • Klinische Forschung Hamburg

    Hamburg

  • Innere Medizin I/Medizinische Klinik

    Heidelberg

  • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl

    Lampertheim

  • ZET-Studien GmbH Leipzig

    Leipzig

  • Internistische Gemeinschaftspraxis

    Mainz

  • Praxis Dr. Wachter

    Mannheim

  • Gemeinschaftspraxis Melcherstaette

    Melcherstaette

  • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler

    Messkirch

  • Praxisgemeinschaft im Kleinen Biergrund

    Offenbach/M

  • Gemeinschaftspraxis Drs. Mockesch

    Weinheim

  • Intermed Institud Fur Klinische Forschung und Arzn

    Wiesbaden

  • Gemeinschaftspraxis Dr. Emden, Frank Drewes

    Worpswede

Other trials in Germany

Netherlands19 sites

  • Andromed Breda

    Breda

  • Middellaan 5

    Breda

  • Andromed Eindhoven

    Eindhoven

  • Bomanshof 8

    Eindhoven

  • Andromed Noord

    Groningen

  • Damsterdiep 9

    Groningen

  • Vasculair Onderzoek Centrum Hoorn

    Hoorn

  • Andromed Leiden

    Leiden

  • Doezastraat 1

    Leiden

  • Andromed Nijmegen

    Nijmegen

  • Kamerlingh Onnesstraat 16-18

    Nijmegen

  • Andromed Rotterdam

    Rotterdam

  • Mathenesserlaan 247

    Rotterdam

  • Albert Schweitzer Ziekenhuis

    Sliedrecht

  • Andromed Oost

    Velp

  • Reigerstraat 30

    Velp

  • Rivierenland Tiel

    Wp Tiel

  • Andromed Zoetermeer

    Zoetermeer

  • Parkdreef 142

    Zoetermeer

Other trials in Netherlands

Spain19 sites

  • Hospital de San Vicente

    Alicante, 03690

  • Hospital Santa Creu I Sant Pau,

    Barcelona, 08025

  • Hospital Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Universitario de Bellvitge

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba

  • Hospital Ramon y Cajal

    Madrid, 28000

  • Centro de Especialidades Pedro Gonzalez Bueno

    Madrid, 28037

  • Fundacion Jimenez Diaz

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Centro de Salud de Ventanielles

    Oviedo, 33010

  • Hospital Clinico S. Juan de Alicante

    San Juan, Alicante

  • Hospital Marques de Valdecilla

    Santander, 3908

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela

  • Hospital Virgen del Roci-o

    Seville, 41013

  • Hospital Dr. Peset

    Valencia, 46017

  • Hospital Clinic i Provincial

    Villaroel, Barcelona

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy10 sites

  • Dipartimento di Medicina Clinica e Biotecnologia Applicata

    Bologna

  • Centro di Ricerca Clinica

    Chieti

  • Gerontologia e Geriatria - Universita degli Studi

    Ferrara

  • Dipartimento di Medicina Interna DIMI

    Genova

  • Universita di Modena e Reggio Emilia, Policlinico

    Modena

  • Dipartimento di Medicina Clinica e Sperimentale

    Naples

  • Medicina Clinica e delle Patologie Emergenti

    Palermo

  • Dipartimento di Medicina Interna e Scienze Biomediche

    Parma

  • U.O Malattie Metaboliche e Diabetologia

    Treviglio

  • Azienda Ospedaliero-Universitaria

    Trieste

Other trials in Italy

Poland10 sites

  • Podlaski Osrodek Kardiologii

    Bialystok

  • NZOZ GCP Dobra Praktyka Lekaska

    Gruziadz

  • NZOZ Terapia Optima

    Katowice

  • NZOZ Esculap, Przychodnia Lekary Rodzinnych

    Łosice

  • NZOZ Centrum, Poradnia Kardiologiczna

    Siedlce

  • Spec. Gab. Lek. Internistyczno-Kardiologicznly

    Tarnów

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

    Tychy

  • Instytut Zywnosci i Zywienia

    Warsaw

  • Lecznica PROSEN SMO

    Warsaw

  • Szpital Wolski im. Dr A. Gostynskiej

    Warsaw

Other trials in Poland

Sweden10 sites

  • Angelholms Sjukhus, Medicinkliniken

    Angelhom

  • Sahlgrenska University Hospital, Intermedicin

    Gothenburg

  • Hjartmottagningen

    Helsingborg

  • Lakarcentrum Nyponet

    Karineholm

  • Medicinkliniken

    Ludvika

  • Huslakaren i Sandviken

    Sandviken

  • Narsjukhuset Sandviken, Kardiologlab, Medicin

    Sandviken

  • Hjart & Karlcenter

    Södertälje

  • Karolinska Universitetssjukhuset

    Stockholm

  • Hjarthuset AB

    Varberg

Other trials in Sweden

Israel9 sites

  • Department of Internal Medicine, Soroka Medical Center

    Beersheva

  • Department of Internal Medicine A, Rambam Medical Center

    Haifa

  • Department of Internal Medicine, Wolfson Medical Center

    Holon

  • Center for Research, Hadassah University Hospital

    Jerusalem Ein Kerem

  • Meir Hospital

    Kfar Saba

  • Department of Medicine, Hadassah Medical Center

    Mount Scopus Jerusalem

  • Department of Internal Medicine, Rivka Sieff Medical Center

    Safed

  • Institute of Metabolic Diseases

    Tel Aviv

  • Institute of Lipid & Atherosclerosis Research

    Tel HaShomer

Other trials in Israel

Denmark6 sites

  • Copenhagen University Hospital

    Copenhagen

  • Medical Center

    Copenhagen

  • Y Forskning, Bispebjerg Hospital

    Copenhagen Nv

  • Frederiks Hospital, Kardiologisk

    Frederiksberg

  • Kolesterollaboratoriet

    Hellerup

  • CCBR A/S

    Vejle

Other trials in Denmark

Finland5 sites

  • Geri-Med Oy

    Helsinki

  • Kaisaniemen Laakariasema

    Helsinki

  • keravan Laakarikeskus

    Helsinki

  • SOK-tyoterveyshuolto

    Tampere

  • TYKS University Hospital

    Turku

Other trials in Finland

Norway5 sites

  • Volvat Medisinske Senter

    Fredrikstad

  • Nyomen Legekontor

    Kongsberg

  • Radhuset Spesialistsenter

    Oslo

  • Rikshospitalet - University Hospital

    Oslo

  • Skedsmo Medisinske Senter A.S.

    Skedsmokorset

Other trials in Norway

About this study

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

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Read the 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.

Being tested
Pitavastatin, Atorvastatin
Keywords
hypercholesterolemia, dyslipidemia, kowa, KRE, pitavastatin, NK-104
Medical subject headings
Dyslipidemias, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12

    Measured: Baseline to 12 weeks

Secondary outcomes (11)

  1. Percent Change From Baseline in Total Cholesterol (TC)

    Percent change in total cholesterol from baseline to Week 12

    Measured: Baseline to 12 Weeks

  2. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)

    percent change from baseline in high density lipoprotein-cholesterol (HDL-C)

    Measured: Baseline to 12 weeks

  3. TC:HDL-C Ratio

    Ratio of mean total cholesterol to mean HDL-C at 12 weeks

    Measured: 12 weeks

  4. Triglycerides (TG)

    mean triglycerides at 12 weeks

    Measured: 12 weeks

  5. Non-HDL:HDL Ratio

    Ratio of non-HDL to HDL at 12 weeks

    Measured: 12 weeks

  6. Apolipoprotein B (Apo B)

    Apolipoprotein B at 12 weeks

    Measured: 12 weeks

  7. Apolipoprotein-A1 (Apo-A1)

    Apolipoprotein-A1 at 12 weeks

    Measured: 12 weeks

  8. Apo-B:Apo-A1 Ratio

    Ratio of Apo-B to Apo-A1 at 12 weeks

    Measured: 12 weeks

  9. High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks

    high sensitivity C-reactive protein (hs-CRP) at 12 weeks

    Measured: 12 weeks

  10. Oxidized LDL at 12 Weeks

    oxidized low density lipoprotein at 12 weeks

    Measured: 12 weeks

  11. National Cholesterol Education Program [NCEP]LDL-C Target Attainment

    Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00249249
Sponsor's protocol ID
NK-104-301
Other IDs
EudraCT number 2005-001000-39
Status last verified
Jan 2010
First submitted
4 Nov 2005
Last updated
12 Jan 2010

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pitavastatin and Atorvastatin in people with Primary Hypercholesterolemia and Dyslipidemia, run by Kowa Research Europe at 192 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United Kingdom, Russia, India, Germany, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12 (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00249249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.

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