Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
NCT ID: NCT00257686
Last Updated: 2010-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
962 participants
INTERVENTIONAL
2005-09-30
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pitavastatin 1 mg
Pitavastatin 1 mg once daily
Pitavastatin
Pravastatin 10 mg
Pravastatin 10 mg once daily
Pravastatin
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
Pitavastatin
Pravastatin 20 mg
Pravastatin 20 mg once daily
Pravastatin
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Pitavastatin
Pravastatin 40 mg
Pravastatin 40 mg once daily
Pravastatin
Interventions
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Pitavastatin
Pravastatin
Eligibility Criteria
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Inclusion Criteria
* Eligible, able to participate, have given informed consent
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia
* Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
* Agree to be available
Exclusion Criteria
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus (HbA1c \>8%).
* Any 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
* Serum CK \>5 x ULRR without clinical explanation
* Uncontrolled hypothyroidism defined as TSH \>ULRR
* Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
* Major surgery, 3 months prior to Visit 1
* Significant 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 ejection fraction \<0.25;
* History of symptomatic cerebrovascular disease
* Any other conditions at the discretion of the investigator
* Known HIV infection
* Poorly controlled or uncontrolled hypertension
* Prior or current 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
* History of hypersensitivity 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
* Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
65 Years
ALL
No
Sponsors
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Kowa Research Europe
INDUSTRY
Responsible Party
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Kowa Research Europe
Principal Investigators
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Dragos Budinski, MD
Role: STUDY_DIRECTOR
Medical Director
Locations
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CCBR A/S
Aalborg, , Denmark
Copenhagen University Hospital
Copenhagen, , Denmark
Medical Center
Copenhagen, , Denmark
CCBR A/S
Vejle, , Denmark
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden / Taunus, , Germany
Praxis Dr. Boenninghoff
Beckum, , Germany
Klinische Forschung Berlin Mitte
Berlin, , Germany
GWT-TUK mbH, Zentrum fur Klinische Studien
Dresden, , 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 Leipzing
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 Melcherstaette
Stuhr-Brinkum, , Germany
Gemeinschaftspraxis Drs. Mockesch
Weinheim, , Germany
Intermed Institud Fur Klinische Forschung und Arzn
Wiesbaden, , Germany
Gemeinschaftspraxis Dr. Emden, Frank Drewes
Worpswede, , Germany
Department of Internal Medicine, Soroka Medical Center
Beersheva, , Israel
Department of Internal Medicine A, Rambal 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
Institue of Lipid & Atherosclerosis Research
Tel Litwinsky, , Israel
Andromed Oost
ES Velp, , Netherlands
Andromed Noord
Groningen, , Netherlands
Vasculair Onderzoek Centrum Hoorn
Hoorn, , Netherlands
Andromed Leiden
Leiden, , Netherlands
Andromed Nijmegen
Rotterdam, , Netherlands
Andromed Rotterdam
Rotterdam, , Netherlands
Albert Schweitzer ziekenhuis
Sliedrecht, , Netherlands
Andromed Breda
VL Breda, , Netherlands
Rivierenland Tiel
WP Tiel, , Netherlands
Andromed Zoetermeer
Zoetermeer, , Netherlands
Albert Schweitzer ziekenhuis
Zwijndrecht, , Netherlands
Oldfield Surgery
Bath, , United Kingdom
St James's Surgery
Bath, , United Kingdom
The Pulteney Practice
Bath, , United Kingdom
Birmingham Clinical Research Centre
Birmingham, , United Kingdom
Stonehill Medical Center
Bolton, , 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
Reading Clinical Research Centre
Reading, , United Kingdom
Elm Lane Surgery
Sheffield, , United Kingdom
Brook Lane Surgery
Southampton, , United Kingdom
Bradford Road Medical Center
Wiltshire, , United Kingdom
Rowden Medical Partnership
Wiltshire, , United Kingdom
The Porch Surgery
Wiltshire, , United Kingdom
The Burns Medical Practice
Yorkshire, , United Kingdom
Countries
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References
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Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013 Feb;20(1):40-53. doi: 10.1177/2047487312451251. Epub 2012 Jun 7.
Other Identifiers
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NK-104-306
Identifier Type: -
Identifier Source: org_study_id
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