Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
- Conditions
- HypercholesterolemiaDyslipidemia
- Interventions
- Registration Number
- NCT00309777
- Lead Sponsor
- Kowa Research Europe
- Brief Summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 857
- Males and females (18-75 years)
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin 2 mg Pitavastatin Pitavastatin 2 mg once daily Simvastatin 20 mg Simvastatin Simvastatin 20 mg once daily Pitavastatin 4 mg Pitavastatin Pitavastatin 4 mg once daily Simvastatin 40 mg Simvastatin Simvastatn 40 mg once daily
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks Baseline to 12 weeks Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
- Secondary Outcome Measures
Name Time Method National Cholesterol Education Program (NCEP) LDL-C Target Attainment 12 week Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12
Trial Locations
- Locations (42)
Radhuset Spesialistsenter
🇳🇴Oslo, Norway
Kemerovo Cardiology Dispensary
🇷🇺Kemerovo, Russian Federation
Keravan Laakarikeskus
🇫🇮Helsinki, Finland
Geri-Med Oy
🇫🇮Helsinki, Finland
Kaisaniemen Laakariasema
🇫🇮Helsinki, Finland
SOK-tyoterveyshuolto
🇫🇮Tampere, Finland
TYKS University Hospital
🇫🇮Turku, Finland
Dipartimento Di Medicina Clinica e Biotecnologia Applicata
🇮🇹Bologna, Italy
Dipartimento di Medicina Interna DIMI
🇮🇹Genova, Italy
Universita di Modena e Reggio Emilia, Policlinico
🇮🇹Modena, Italy
Centro di Ricerca Clinica
🇮🇹Chieti, Italy
Gerontologia e Geriatria - Universita degli Studi
🇮🇹Ferrara, 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
Dipartimento di Medicina Clinica e Sperimentale
🇮🇹Napoli, Italy
Azienda Ospedaliero-Universitaria
🇮🇹Trieste, Italy
Nyomen Legekontor
🇳🇴Kongsberg, Norway
Volvat Medisinske Senter
🇳🇴Fredrikstad, Norway
Rikshospitalet - University Hospital
🇳🇴Oslo, Norway
Skedsmo Medisinske Senter A.S.
🇳🇴Skedsmokorset, Norway
Central Clinical Hospital 1 of RZD
🇷🇺Moscow, Russian Federation
Novosibirsk Reg. Clinical Cardiology Dispensary
🇷🇺Novosibirsk, Russian Federation
Moscow City Clinical Hospital 68
🇷🇺Moscow, Russian Federation
City Clinical Hospital 64
🇷🇺Moscow, Russian Federation
City Clinical Hospital 23
🇷🇺Moscow, Russian Federation
State Research Center for Preventive Medicine
🇷🇺Moscow, Russian Federation
Clinical Hospital of Russian Academy of Sciences
🇷🇺Saint Petersburg, Russian Federation
Central Medical Unit 122, St. Pb
🇷🇺Saint Petersburg, Russian Federation
Consulting and Diagnostic Center 85
🇷🇺Saint Petersburg, Russian Federation
Krestovsky Island Medical Institute
🇷🇺Saint Petersburg, Russian Federation
St Michael's Partnership
🇬🇧Bath, United Kingdom
Avondale Surgery
🇬🇧Chesterfield, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
Box Surgery
🇬🇧Wiltshire, United Kingdom
Pokrovskaya City Hospital
🇷🇺Saint Petersburg, Russian Federation
The Burngreave Surgery
🇬🇧Sheffield, United Kingdom
Eastleigh Surgery
🇬🇧Wiltshire, United Kingdom
St Helier Hospital
🇬🇧Surrey, United Kingdom
Lovemead Group Practice
🇬🇧Wiltshire, United Kingdom
St Chad's Surgery
🇬🇧Wiltshire, United Kingdom
The Health Centre
🇬🇧Wiltshire, United Kingdom