Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
1 other identifier
interventional
545
5 countries
59
Brief Summary
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedMarch 16, 2010
March 1, 2010
1.5 years
May 26, 2006
August 26, 2009
March 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Baseline to 60 weeks
Secondary Outcomes (1)
Change From Baseline in Total Cholesterol
Baseline to 60 weeks
Study Arms (2)
Pitavastatin 2 mg QD
EXPERIMENTALPitavastatin 2 mg once daily
Pitavastatin 4 mg QD
EXPERIMENTALPitavastatin 4 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
You may not qualify if:
- Failed to complete study NK-104-306(NCT00257686)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Copenhagen University Hospital
Copenhagen, Denmark
Medical Center
Copenhagen, Denmark
CCBR A/S
Vejle, Denmark
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden/Taunus, Germany
Praxis Dr. Boenninghoff
Beckum, Germany
Klinische Forschung Berlin Mitte
Berlin, Germany
GWT-TUK GmbH, 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 Leipzig
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 Drs. Mockesch
Weinheim, Germany
Intermed Institud Fur Klinische Forschung und Arzn
Wiesbaden, Germany
Gemeinschaftspraxis Dr. Emden, Frank Drewes
Worpswede, Germany
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
Institute of Lipid & Atherosclerosis Research
Tel Litwinsky, Israel
Andromed Breda
Breda, Netherlands
Andromed Noord
Groningen, Netherlands
Vasculair Onderzoek Centrum Hoorn
Hoorn, Netherlands
Andromed Leiden
Leiden, Netherlands
Andromed Nijmegen
Nijmegen, Netherlands
Andromed Rotterdam
Rotterdam, Netherlands
Albert Schweitzer Ziekenhuis
Sliedrecht, Netherlands
Rivierenland Tiel
Tiel, Netherlands
Andromed Oost
Velp, Netherlands
Andromed Zoetermeer
Zoetermeer, Netherlands
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, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bill Arana
- Organization
- Kowa Research Institute
Study Officials
- STUDY DIRECTOR
Dragos Budinski, MD
Medical Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 26, 2006
First Posted
May 29, 2006
Study Start
June 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 16, 2010
Results First Posted
January 18, 2010
Record last verified: 2010-03