Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
- Registration Number
- NCT00330876
- Lead Sponsor
- Kowa Research Europe
- Brief Summary
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
- Detailed Description
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 545
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
- Failed to complete study NK-104-306(NCT00257686)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin 4 mg QD Pitavastatin Pitavastatin 4 mg once daily Pitavastatin 2 mg QD Pitavastatin Pitavastatin 2 mg once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in LDL-C Baseline to 60 weeks percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total Cholesterol Baseline to 60 weeks Percent change from baseline in total cholesterol (TC)
Trial Locations
- Locations (59)
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
Andromed Noord
🇳🇱Groningen, Netherlands
Andromed Nijmegen
🇳🇱Nijmegen, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Sliedrecht, Netherlands
Rivierenland Tiel
🇳🇱Tiel, Netherlands
Andromed Oost
🇳🇱Velp, Netherlands
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands
Praxis Dr. Boenninghoff
🇩🇪Beckum, Germany
Department of Internal Medicine A, Rambal Medical Center
🇮🇱Haifa, Israel
Department of Internal Medicine, Wolfson Medical Center
🇮🇱Holon, Israel
Gemeinschaftspraxis Dr. Emden, Frank Drewes
🇩🇪Worpswede, Germany
GWT-TUK GmbH, Zentrum fur Klinische Studien
🇩🇪Dresden, Germany
Praxis Dr. Wachter
🇩🇪Mannheim, Germany
Kardiologische Gemeinschaftspraxis Prof. Reifart
🇩🇪Bad Soden/Taunus, Germany
Klinische Forschung Berlin Mitte
🇩🇪Berlin, Germany
Innere Medizin I/Medizinische Klinik
🇩🇪Heidelberg, Germany
Gemeinschaftspraxis Melcherstaette
🇩🇪Melcherstaette, Germany
Andromed Breda
🇳🇱Breda, Netherlands
Andromed Leiden
🇳🇱Leiden, Netherlands
Birmingham Clinical Research Centre
🇬🇧Birmingham, United Kingdom
Chorley Clinical Research Centre
🇬🇧Chorley, United Kingdom
Gomersal Lane Surgery
🇬🇧Dronfield, United Kingdom
Townhead Research
🇬🇧Irvine, United Kingdom
Gemeinschaftspraxis Dr. Krause, Th. Menke
🇩🇪Goch, Germany
Internistische Gemeinschaftspraxis
🇩🇪Mainz, Germany
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪Messkirch, Germany
ZET-Studien GmbH Leipzig
🇩🇪Leipzig, Germany
Gemeinschaftspraxis Drs. Mockesch
🇩🇪Weinheim, Germany
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
🇩🇪Lampertheim, Germany
Department of Internal Medicine, Soroka Medical Center
🇮🇱Beersheva, Israel
Andromed Rotterdam
🇳🇱Rotterdam, Netherlands
The Pulteney Practice
🇬🇧Bath, United Kingdom
Bradford Road Medical Center
🇬🇧Wiltshire, United Kingdom
Intermed Institud Fur Klinische Forschung und Arzn
🇩🇪Wiesbaden, Germany
Institute of Lipid & Atherosclerosis Research
🇮🇱Tel Hashomer, Israel
Vasculair Onderzoek Centrum Hoorn
🇳🇱Hoorn, Netherlands
Oldfield Surgery
🇬🇧Bath, United Kingdom
Medical Center
🇩🇰Copenhagen, Denmark
CCBR A/S
🇩🇰Vejle, Denmark
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
St James's Surgery
🇬🇧Bath, United Kingdom
Stonehill Medical Center
🇬🇧Bolton, United Kingdom
Saltash Health Center
🇬🇧Cornwall, United Kingdom
The Symons Medical Center
🇬🇧Maidenhead, United Kingdom
Manchester Clinical Research Centre
🇬🇧Manchester, United Kingdom
Greenwood Medical Center
🇬🇧Nottingham, United Kingdom
Elm Lane Surgery
🇬🇧Sheffield, United Kingdom
Brook Lane Surgery
🇬🇧Southampton, United Kingdom
Rowden Medical Partnership
🇬🇧Wiltshire, United Kingdom
The Porch Surgery
🇬🇧Wiltshire, United Kingdom
Praxisgemeinschaft im Kleinen Biergrund
🇩🇪Offenbach/M, Germany
Crosby Clinical Research Centre
🇬🇧Liverpool, United Kingdom
Reading Clinical Research Centre
🇬🇧Reading, United Kingdom
The Burns Medical Practice
🇬🇧Yorkshire, United Kingdom