Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
Hypercholesterolemia or Combined Dyslipidemia
About this trial
This is an interventional treatment trial for Hypercholesterolemia or Combined Dyslipidemia focused on measuring Kowa, Hypercholesterolemia, combined, dyslipidemia, elderly, pitavastatin, NK-104
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.
Sites / Locations
- CCBR A/S
- Copenhagen University Hospital
- Medical Center
- CCBR A/S
- Kardiologische Gemeinschaftspraxis Prof. Reifart
- Praxis Dr. Boenninghoff
- Klinische Forschung Berlin Mitte
- GWT-TUK mbH, Zentrum fur Klinische Studien
- Gemeinschaftspraxis Dr. Krause, Th. Menke
- Klinische Forschung Hamburg
- Innere Medizin I / Medizinische Klinik
- Gemeinschaftspraxis H. Holz Dr. med, K. W. Klingl
- ZET-Studien GmbH Leipzing
- Internistische Gemeinschaftspraxis
- Praxis Dr. Wachter
- Gemeinschaftspraxis Melcherstaette
- Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
- Praxisgemeinschaft im Kleinen Biergrund
- Gemeinschaftspraxis Melcherstaette
- Gemeinschaftspraxis Drs. Mockesch
- Intermed Institud Fur Klinische Forschung und Arzn
- Gemeinschaftspraxis Dr. Emden, Frank Drewes
- Department of Internal Medicine, Soroka Medical Center
- Department of Internal Medicine A, Rambal Medical Center
- Department of Internal Medicine, Wolfson Medical Center
- Center for Research, Hadassah University Hospital
- Meir Hospital
- Department of Medicine, Hadassah Medical Center
- Department of Internal Medicine, Rivka Sieff Medical Center
- Institute of Metabolic Diseases
- Institue of Lipid & Atherosclerosis Research
- Andromed Oost
- Andromed Noord
- Vasculair Onderzoek Centrum Hoorn
- Andromed Leiden
- Andromed Nijmegen
- Andromed Rotterdam
- Albert Schweitzer ziekenhuis
- Andromed Breda
- Rivierenland Tiel
- Andromed Zoetermeer
- Albert Schweitzer ziekenhuis
- Oldfield Surgery
- St James's Surgery
- The Pulteney Practice
- Birmingham Clinical Research Centre
- Stonehill Medical Center
- Chorley Clinical Research Centre
- Saltash Health Center
- Gomersal Lane Surgery
- Townhead Research
- Crosby Clinical Research Centre
- The Symons Medical Center
- Manchester Clinical Research Centre
- Greenwood Medical Center
- Reading Clinical Research Centre
- Elm Lane Surgery
- Brook Lane Surgery
- Bradford Road Medical Center
- Rowden Medical Partnership
- The Porch Surgery
- The Burns Medical Practice
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Pitavastatin 1 mg
Pravastatin 10 mg
Pitavastatin 2 mg
Pravastatin 20 mg
Pitavastatin 4 mg
Pravastatin 40 mg
Pitavastatin 1 mg once daily
Pravastatin 10 mg once daily
Pitavastatin 2 mg once daily
Pravastatin 20 mg once daily
Pitavastatin 4 mg once daily
Pravastatin 40 mg once daily