Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
2 other identifiers
interventional
857
5 countries
42
Brief Summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
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
42 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 11, 2005
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
December 16, 2009
CompletedJanuary 12, 2010
January 1, 2010
1.1 years
November 11, 2005
August 26, 2009
January 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Baseline to 12 weeks
Secondary Outcomes (1)
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
12 week
Study Arms (4)
Pitavastatin 2 mg
EXPERIMENTALPitavastatin 2 mg once daily
Simvastatin 20 mg
ACTIVE COMPARATORSimvastatin 20 mg once daily
Pitavastatin 4 mg
EXPERIMENTALPitavastatin 4 mg once daily
Simvastatin 40 mg
ACTIVE COMPARATORSimvastatn 40 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Males and females (18-75 years)
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
You may not qualify if:
- Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
- Conditions which may cause secondary dyslipidemia.
- Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
- Abnormal serum creatine kinase (CK) above the pre-specified level
- Abnormal pancreatic, liver or renal function
- Significant heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Geri-Med Oy
Helsinki, Finland
Kaisaniemen Laakariasema
Helsinki, Finland
Keravan Laakarikeskus
Helsinki, Finland
SOK-tyoterveyshuolto
Tampere, Finland
TYKS University Hospital
Turku, Finland
Dipartimento Di Medicina Clinica e Biotecnologia Applicata
Bologna, Italy
Centro di Ricerca Clinica
Chieti, Italy
Gerontologia e Geriatria - Universita degli Studi
Ferrara, Italy
Dipartimento di Medicina Interna DIMI
Genova, Italy
Universita di Modena e Reggio Emilia, Policlinico
Modena, Italy
Dipartimento di Medicina Clinica e Sperimentale
Napoli, Italy
Medicina Clinica e delle Patologie Emergenti
Palermo, Italy
Dipartimento di Medicina Interna e Scienze Biomediche
Parma, Italy
U.O Malattie Metaboliche e Diabetologia
Treviglio, Italy
Azienda Ospedaliero-Universitaria
Trieste, Italy
Volvat Medisinske Senter
Fredrikstad, Norway
Nyomen Legekontor
Kongsberg, Norway
Radhuset Spesialistsenter
Oslo, Norway
Rikshospitalet - University Hospital
Oslo, Norway
Skedsmo Medisinske Senter A.S.
Skedsmokorset, Norway
Kemerovo Cardiology Dispensary
Kemerovo, Russia
Central Clinical Hospital 1 of RZD
Moscow, Russia
City Clinical Hospital 23
Moscow, Russia
City Clinical Hospital 64
Moscow, Russia
Moscow City Clinical Hospital 68
Moscow, Russia
State Research Center for Preventive Medicine
Moscow, Russia
Novosibirsk Reg. Clinical Cardiology Dispensary
Novosibirsk, Russia
Central Medical Unit 122, St. Pb
Saint Petersburg, Russia
Clinical Hospital of Russian Academy of Sciences
Saint Petersburg, Russia
Consulting and Diagnostic Center 85
Saint Petersburg, Russia
Krestovsky Island Medical Institute
Saint Petersburg, Russia
Pokrovskaya City Hospital
Saint Petersburg, Russia
St Michael's Partnership
Bath, United Kingdom
Avondale Surgery
Chesterfield, United Kingdom
Knowle House Surgery
Plymouth, United Kingdom
The Burngreave Surgery
Sheffield, United Kingdom
St Helier Hospital
Surrey, United Kingdom
Box Surgery
Wiltshire, United Kingdom
Eastleigh Surgery
Wiltshire, United Kingdom
Lovemead Group Practice
Wiltshire, United Kingdom
St Chad's Surgery
Wiltshire, United Kingdom
The Health Centre
Wiltshire, United Kingdom
Related Publications (1)
Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009 Nov;25(11):2755-64. doi: 10.1185/03007990903290886.
PMID: 19785568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neil Hounslow
- Organization
- Kowa Research Europe, Ltd.
Study Officials
- STUDY DIRECTOR
Dragos Budinski, Med Dr.
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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2005
First Posted
April 3, 2006
Study Start
September 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
January 12, 2010
Results First Posted
December 16, 2009
Record last verified: 2010-01