Hypercholesterolemia or Combined Dyslipidemia Clinical Trial
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
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
| Status | Completed |
| Enrollment | 962 |
| Est. completion date | May 2006 |
| Est. primary completion date | May 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | CCBR A/S | Aalborg | |
| Denmark | Copenhagen University Hospital | Copenhagen | |
| Denmark | Medical Center | Copenhagen | |
| Denmark | CCBR A/S | Vejle | |
| Germany | 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 | |
| Israel | 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 Hashomer | |
| Netherlands | 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 | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Kowa Research Europe |
Denmark, Germany, Israel, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C | Percent change from baseline in low density cholesterol (LDL-C) | Baseline to 12 weeks | No |
| Secondary | Percent Change From Baseline in TC | Percent change from baseline in total cholesterol (TC) | Baseline to 12 weeks | No |