Clinical trial NCT00257686: Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
Official title: Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia or Combined Dyslipidemia
Keywords: Kowa
Hypercholesterolemia
combined
dyslipidemia
elderly
pitavastatin
NK-104
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 962
Sex: ALL
Minimum age (years): 65
Standard ages: 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 and safety of pitavastatin with that of pravastatin in elderly patients

Detailed description: Following a wash-out dietary lead-in period, patients will receive either Preavastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Eligibility criteria: Inclusion Criteria:

* Males and postmenopausal females (aged 65 years and older
* 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

* Homozygous familial hypercholesterolemia
* 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.

Primary outcomes:
measure: Percent Change From Baseline in LDL-C
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in TC
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR A/S
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Copenhagen
country: Denmark
facility: Medical Center
city: Vejle
country: Denmark
facility: CCBR A/S
city: Bad Soden / Taunus
country: Germany
facility: Kardiologische Gemeinschaftspraxis Prof. Reifart
city: Beckum
country: Germany
facility: Praxis Dr. Boenninghoff
city: Berlin
country: Germany
facility: Klinische Forschung Berlin Mitte
city: Dresden
country: Germany
facility: GWT-TUK mbH, Zentrum fur Klinische Studien
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 Leipzing
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: Stuhr-Brinkum
country: Germany
facility: Gemeinschaftspraxis Melcherstaette
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: Beersheva
country: Israel
facility: Department of Internal Medicine, Soroka Medical Center
city: Haifa
country: Israel
facility: Department of Internal Medicine A, Rambal 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: Institue of Lipid & Atherosclerosis Research
city: ES Velp
country: Netherlands
facility: Andromed Oost
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum Hoorn
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Rotterdam
country: Netherlands
facility: Andromed Nijmegen
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Sliedrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: VL Breda
country: Netherlands
facility: Andromed Breda
city: WP Tiel
country: Netherlands
facility: Rivierenland Tiel
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Bath
country: United Kingdom
facility: Oldfield Surgery
city: Bath
country: United Kingdom
facility: St James's Surgery
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: 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: Reading
country: United Kingdom
facility: Reading Clinical Research Centre
city: Sheffield
country: United Kingdom
facility: Elm Lane Surgery
city: Southampton
country: United Kingdom
facility: Brook Lane Surgery
city: Wiltshire
country: United Kingdom
facility: Bradford Road Medical Center
city: Wiltshire
country: United Kingdom
facility: Rowden Medical Partnership
city: Wiltshire
country: United Kingdom
facility: The Porch Surgery
city: Yorkshire
country: United Kingdom
facility: The Burns Medical Practice
Study officials:
affiliation: Medical Director
name: Dragos Budinski, MD
role: STUDY_DIRECTOR
References:
citation: 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.