Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
- Conditions
- Hypercholesterolemia or Combined Dyslipidemia
- Interventions
- Registration Number
- NCT00257686
- Lead Sponsor
- Kowa Research Europe
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 962
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin 4 mg Pitavastatin Pitavastatin 4 mg once daily Pravastatin 40 mg Pravastatin Pravastatin 40 mg once daily Pitavastatin 2 mg Pitavastatin Pitavastatin 2 mg once daily Pitavastatin 1 mg Pitavastatin Pitavastatin 1 mg once daily Pravastatin 10 mg Pravastatin Pravastatin 10 mg once daily Pravastatin 20 mg Pravastatin Pravastatin 20 mg once daily
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in LDL-C Baseline to 12 weeks Percent change from baseline in low density cholesterol (LDL-C)
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in TC Baseline to 12 weeks Percent change from baseline in total cholesterol (TC)
Trial Locations
- Locations (59)
Vasculair Onderzoek Centrum Hoorn
🇳🇱Hoorn, Netherlands
CCBR A/S
🇩🇰Vejle, Denmark
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Medical Center
🇩🇰Copenhagen, Denmark
Kardiologische Gemeinschaftspraxis Prof. Reifart
🇩🇪Bad Soden / Taunus, Germany
Klinische Forschung Berlin Mitte
🇩🇪Berlin, Germany
Gemeinschaftspraxis Dr. Krause, Th. Menke
🇩🇪Goch, Germany
Gemeinschaftspraxis Melcherstaette
🇩🇪Stuhr-Brinkum, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪Messkirch, Germany
Praxisgemeinschaft im Kleinen Biergrund
🇩🇪Offenbach/M, Germany
Andromed Oost
🇳🇱ES Velp, Netherlands
Department of Medicine, Hadassah Medical Center
🇮🇱Mount Scopus Jerusalem, Israel
Gemeinschaftspraxis Dr. Emden, Frank Drewes
🇩🇪Worpswede, Germany
Department of Internal Medicine, Rivka Sieff Medical Center
🇮🇱Safed, Israel
Andromed Noord
🇳🇱Groningen, Netherlands
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands
Stonehill Medical Center
🇬🇧Bolton, United Kingdom
Albert Schweitzer ziekenhuis
🇳🇱Zwijndrecht, Netherlands
Andromed Breda
🇳🇱VL Breda, Netherlands
Oldfield Surgery
🇬🇧Bath, United Kingdom
Elm Lane Surgery
🇬🇧Sheffield, United Kingdom
Gomersal Lane Surgery
🇬🇧Dronfield, United Kingdom
Brook Lane Surgery
🇬🇧Southampton, United Kingdom
Manchester Clinical Research Centre
🇬🇧Manchester, United Kingdom
Bradford Road Medical Center
🇬🇧Wiltshire, United Kingdom
Reading Clinical Research Centre
🇬🇧Reading, United Kingdom
Rowden Medical Partnership
🇬🇧Wiltshire, United Kingdom
The Porch Surgery
🇬🇧Wiltshire, United Kingdom
Gemeinschaftspraxis Drs. Mockesch
🇩🇪Weinheim, Germany
Intermed Institud Fur Klinische Forschung und Arzn
🇩🇪Wiesbaden, Germany
Rivierenland Tiel
🇳🇱WP Tiel, Netherlands
Praxis Dr. Boenninghoff
🇩🇪Beckum, Germany
GWT-TUK mbH, Zentrum fur Klinische Studien
🇩🇪Dresden, Germany
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
Innere Medizin I / Medizinische Klinik
🇩🇪Heidelberg, Germany
ZET-Studien GmbH Leipzing
🇩🇪Leipzig, Germany
Department of Internal Medicine, Wolfson Medical Center
🇮🇱Holon, Israel
Internistische Gemeinschaftspraxis
🇩🇪Mainz, Germany
Praxis Dr. Wachter
🇩🇪Mannheim, Germany
Gemeinschaftspraxis H. Holz Dr. med, K. W. Klingl
🇩🇪Lampertheim, Germany
Center for Research, Hadassah University Hospital
🇮🇱Jerusalem Ein Kerem, Israel
Department of Internal Medicine, Soroka Medical Center
🇮🇱Beersheva, Israel
Meir Hospital
🇮🇱Kfar Saba, Israel
Department of Internal Medicine A, Rambal Medical Center
🇮🇱Haifa, Israel
Institue of Lipid & Atherosclerosis Research
🇮🇱Tel Hashomer, Israel
Institute of Metabolic Diseases
🇮🇱Tel Aviv, Israel
Andromed Leiden
🇳🇱Leiden, Netherlands
Andromed Nijmegen
🇳🇱Rotterdam, Netherlands
Andromed Rotterdam
🇳🇱Rotterdam, Netherlands
St James's Surgery
🇬🇧Bath, United Kingdom
The Pulteney Practice
🇬🇧Bath, United Kingdom
Birmingham Clinical Research Centre
🇬🇧Birmingham, United Kingdom
Saltash Health Center
🇬🇧Cornwall, United Kingdom
Chorley Clinical Research Centre
🇬🇧Chorley, United Kingdom
The Symons Medical Center
🇬🇧Maidenhead, United Kingdom
Crosby Clinical Research Centre
🇬🇧Liverpool, United Kingdom
Townhead Research
🇬🇧Irvine, United Kingdom
Greenwood Medical Center
🇬🇧Nottingham, United Kingdom
The Burns Medical Practice
🇬🇧Yorkshire, United Kingdom