Clinical trial NCT00309777: Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Official title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidemia
Keywords: hypercholesterolemia
kowa
dyslipidemia
pitavastatin
NK-104
Primary Hypercholesterolemia or Combined Dyslipidemia
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 857
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Eligibility criteria: Inclusion Criteria:

* Males and females (18-75 years)
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: National Cholesterol Education Program (NCEP) LDL-C Target Attainment
timeFrame: 12 week
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Geri-Med Oy
city: Helsinki
country: Finland
facility: Kaisaniemen Laakariasema
city: Helsinki
country: Finland
facility: Keravan Laakarikeskus
city: Tampere
country: Finland
facility: SOK-tyoterveyshuolto
city: Turku
country: Finland
facility: TYKS University Hospital
city: Bologna
country: Italy
facility: Dipartimento Di Medicina Clinica e Biotecnologia Applicata
city: Chieti
country: Italy
facility: Centro di Ricerca Clinica
city: Ferrara
country: Italy
facility: Gerontologia e Geriatria - Universita degli Studi
city: Genova
country: Italy
facility: Dipartimento di Medicina Interna DIMI
city: Modena
country: Italy
facility: Universita di Modena e Reggio Emilia, Policlinico
city: Napoli
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale
city: Palermo
country: Italy
facility: Medicina Clinica e delle Patologie Emergenti
city: Parma
country: Italy
facility: Dipartimento di Medicina Interna e Scienze Biomediche
city: Treviglio
country: Italy
facility: U.O Malattie Metaboliche e Diabetologia
city: Trieste
country: Italy
facility: Azienda Ospedaliero-Universitaria
city: Fredrikstad
country: Norway
facility: Volvat Medisinske Senter
city: Kongsberg
country: Norway
facility: Nyomen Legekontor
city: Oslo
country: Norway
facility: Radhuset Spesialistsenter
city: Oslo
country: Norway
facility: Rikshospitalet - University Hospital
city: Skedsmokorset
country: Norway
facility: Skedsmo Medisinske Senter A.S.
city: Kemerovo
country: Russian Federation
facility: Kemerovo Cardiology Dispensary
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital 1 of RZD
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 23
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 64
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital 68
city: Moscow
country: Russian Federation
facility: State Research Center for Preventive Medicine
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Reg. Clinical Cardiology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Central Medical Unit 122, St. Pb
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital of Russian Academy of Sciences
city: Saint Petersburg
country: Russian Federation
facility: Consulting and Diagnostic Center 85
city: Saint Petersburg
country: Russian Federation
facility: Krestovsky Island Medical Institute
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya City Hospital
city: Bath
country: United Kingdom
facility: St Michael's Partnership
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
city: Sheffield
country: United Kingdom
facility: The Burngreave Surgery
city: Surrey
country: United Kingdom
facility: St Helier Hospital
city: Wiltshire
country: United Kingdom
facility: Box Surgery
city: Wiltshire
country: United Kingdom
facility: Eastleigh Surgery
city: Wiltshire
country: United Kingdom
facility: Lovemead Group Practice
city: Wiltshire
country: United Kingdom
facility: St Chad's Surgery
city: Wiltshire
country: United Kingdom
facility: The Health Centre
Study officials:
affiliation: Medical Director
name: Dragos Budinski, Med Dr.
role: STUDY_DIRECTOR
References:
citation: 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.