Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
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
1 other identifier
interventional
962
5 countries
62
Brief Summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
Shorter than P25 for phase_3
62 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
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedMarch 16, 2010
March 1, 2010
8 months
November 21, 2005
August 26, 2009
March 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in LDL-C
Percent change from baseline in low density cholesterol (LDL-C)
Baseline to 12 weeks
Secondary Outcomes (1)
Percent Change From Baseline in TC
Baseline to 12 weeks
Study Arms (6)
Pitavastatin 1 mg
EXPERIMENTALPitavastatin 1 mg once daily
Pravastatin 10 mg
ACTIVE COMPARATORPravastatin 10 mg once daily
Pitavastatin 2 mg
EXPERIMENTALPitavastatin 2 mg once daily
Pravastatin 20 mg
ACTIVE COMPARATORPravastatin 20 mg once daily
Pitavastatin 4 mg
EXPERIMENTALPitavastatin 4 mg once daily
Pravastatin 40 mg
ACTIVE COMPARATORPravastatin 40 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
CCBR A/S
Aalborg, Denmark
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 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, 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
Institue of Lipid & Atherosclerosis Research
Tel Litwinsky, Israel
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, 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
Related Publications (1)
Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013 Feb;20(1):40-53. doi: 10.1177/2047487312451251. Epub 2012 Jun 7.
PMID: 22679249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 23, 2005
Study Start
September 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
March 16, 2010
Results First Posted
January 18, 2010
Record last verified: 2010-03