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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249249
• Other study ID #: NK-104-301
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2005
• Last updated: January 7, 2010
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2010
• Source: Kowa Research Europe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesIndia: Indian Council of Medical ResearchRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• Pitavastatin

• Atorvastatin

Locations

Country	Name	City	State
Denmark	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
Finland	Geri-Med Oy	Helsinki
Finland	Kaisaniemen Laakariasema	Helsinki
Finland	keravan Laakarikeskus	Helsinki
Finland	SOK-tyoterveyshuolto	Tampere
Finland	TYKS University Hospital	Turku
Germany	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
India	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	King Edward Medical College & Hospital	Maharashtra
India	Lokmanya Hospital	Maharashtra
India	LTMMC & General Hospital	Maharashtra
India	Ruby Hall Clinic	Maharashtra
India	Sir J. J. Group of Hospitals	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
Israel	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 Hashomer
Italy	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
Netherlands	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
Norway	Volvat Medisinske Senter	Fredrikstad
Norway	Nyomen Legekontor	Kongsberg
Norway	Radhuset Spesialistsenter	Oslo
Norway	Rikshospitalet - University Hospital	Oslo
Norway	Skedsmo Medisinske Senter A.S.	Skedsmokorset
Poland	Podlaski Osrodek Kardiologii	Bialystok
Poland	NZOZ GCP Dobra Praktyka Lekaska	Gruziadz
Poland	NZOZ Terapia Optima	Katowice
Poland	NZOZ Esculap, Przychodnia Lekary Rodzinnych	Losice
Poland	NZOZ Centrum, Poradnia Kardiologiczna	Siedlce
Poland	Spec. Gab. Lek. Internistyczno-Kardiologicznly	Tarnow
Poland	Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego	Tychy
Poland	Instytut Zywnosci i Zywienia	Warszawa
Poland	Lecznica PROSEN SMO	Warszawa
Poland	Szpital Wolski im. Dr A. Gostynskiej	Warszawa
Russian Federation	Kemerovo Cardiology Dispensary	Kemerovo
Russian Federation	Central Clinical Hospital 1 of RZD	Moscow
Russian Federation	City Clinical Hospital 23	Moscow
Russian Federation	City Clinical Hospital 64	Moscow
Russian Federation	Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management	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	Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy	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�, 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	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	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	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	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	State Research Center for Preventive Medicine	Moscow
Russian Federation	Novosibirsk Reg. Clinical Cardiology Dispensary	Novosibirsk
Russian Federation	Central Medical Unit 122, St. Pb	Saint Petersburg
Russian Federation	Clinical Hospital of Russian Academy of Sciences	Saint Petersburg
Russian Federation	Consulting and Diagnostic Center 85	Saint Petersburg
Russian Federation	Krestovsky Island Medical Institute	Saint Petersburg
Russian Federation	Pokrovskaya City Hospital	Saint Petersburg
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	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	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
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	Cordoba
Spain	Centro de Especialidades Pedro Gonzalez Bueno	Madrid
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Centro de Salud de Ventanielles	Oviedo
Spain	Hospital Clinico S. Juan de Alicante	San Juan	Alicante
Spain	Hospital Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela
Spain	Hospital Virgen del Roci-o	Sevilla
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital Clinic i Provincial	Villaroel	Barcelona
Spain	Hospital Clinico Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza
Sweden	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	Sodertalje
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Hjarthuset AB	Varberg
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Europe

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  India,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12		Baseline to 12 weeks	No
Secondary	Percent Change From Baseline in Total Cholesterol (TC)		Baseline to 12 Weeks	No
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)		Baseline to 12 weeks	No
Secondary	TC:HDL-C Ratio		12 weeks	No
Secondary	Triglycerides (TG)		12 weeks	No
Secondary	Non-HDL:HDL Ratio		12 weeks	No
Secondary	Apolipoprotein B (Apo B)		12 weeks	No
Secondary	Apolipoprotein-A1 (Apo-A1)		12 weeks	No
Secondary	Apo-B:Apo-A1 Ratio		12 weeks	No
Secondary	High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks		12 weeks	No
Secondary	Oxidized LDL at 12 Weeks		12 weeks	No
Secondary	National Cholesterol Education Program [NCEP]LDL-C Target Attainment		up to 12 weeks	No