search
Back to results

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pitavastatin
Simvastatin
Sponsored by
Kowa Research Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geri-Med Oy
  • Kaisaniemen Laakariasema
  • Keravan Laakarikeskus
  • SOK-tyoterveyshuolto
  • TYKS University Hospital
  • Dipartimento Di Medicina Clinica e Biotecnologia Applicata
  • Centro di Ricerca Clinica
  • Gerontologia e Geriatria - Universita degli Studi
  • Dipartimento di Medicina Interna DIMI
  • Universita di Modena e Reggio Emilia, Policlinico
  • Dipartimento di Medicina Clinica e Sperimentale
  • Medicina Clinica e delle Patologie Emergenti
  • Dipartimento di Medicina Interna e Scienze Biomediche
  • U.O Malattie Metaboliche e Diabetologia
  • Azienda Ospedaliero-Universitaria
  • Volvat Medisinske Senter
  • Nyomen Legekontor
  • Radhuset Spesialistsenter
  • Rikshospitalet - University Hospital
  • Skedsmo Medisinske Senter A.S.
  • Kemerovo Cardiology Dispensary
  • Central Clinical Hospital 1 of RZD
  • City Clinical Hospital 23
  • City Clinical Hospital 64
  • Moscow City Clinical Hospital 68
  • State Research Center for Preventive Medicine
  • Novosibirsk Reg. Clinical Cardiology Dispensary
  • Central Medical Unit 122, St. Pb
  • Clinical Hospital of Russian Academy of Sciences
  • Consulting and Diagnostic Center 85
  • Krestovsky Island Medical Institute
  • Pokrovskaya City Hospital
  • St Michael's Partnership
  • Avondale Surgery
  • Knowle House Surgery
  • The Burngreave Surgery
  • St Helier Hospital
  • Box Surgery
  • Eastleigh Surgery
  • Lovemead Group Practice
  • St Chad's Surgery
  • The Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Pitavastatin 2 mg

Simvastatin 20 mg

Pitavastatin 4 mg

Simvastatin 40 mg

Arm Description

Pitavastatin 2 mg once daily

Simvastatin 20 mg once daily

Pitavastatin 4 mg once daily

Simvastatn 40 mg once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

National Cholesterol Education Program (NCEP) LDL-C Target Attainment
Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12

Full Information

First Posted
November 11, 2005
Last Updated
January 7, 2010
Sponsor
Kowa Research Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT00309777
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
857 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 2 mg
Arm Type
Experimental
Arm Description
Pitavastatin 2 mg once daily
Arm Title
Simvastatin 20 mg
Arm Type
Active Comparator
Arm Description
Simvastatin 20 mg once daily
Arm Title
Pitavastatin 4 mg
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Arm Title
Simvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Simvastatn 40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin once daily
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Simvastatin once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
Description
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
Description
Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, Med Dr.
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Geri-Med Oy
City
Helsinki
Country
Finland
Facility Name
Kaisaniemen Laakariasema
City
Helsinki
Country
Finland
Facility Name
Keravan Laakarikeskus
City
Helsinki
Country
Finland
Facility Name
SOK-tyoterveyshuolto
City
Tampere
Country
Finland
Facility Name
TYKS University Hospital
City
Turku
Country
Finland
Facility Name
Dipartimento Di Medicina Clinica e Biotecnologia Applicata
City
Bologna
Country
Italy
Facility Name
Centro di Ricerca Clinica
City
Chieti
Country
Italy
Facility Name
Gerontologia e Geriatria - Universita degli Studi
City
Ferrara
Country
Italy
Facility Name
Dipartimento di Medicina Interna DIMI
City
Genova
Country
Italy
Facility Name
Universita di Modena e Reggio Emilia, Policlinico
City
Modena
Country
Italy
Facility Name
Dipartimento di Medicina Clinica e Sperimentale
City
Napoli
Country
Italy
Facility Name
Medicina Clinica e delle Patologie Emergenti
City
Palermo
Country
Italy
Facility Name
Dipartimento di Medicina Interna e Scienze Biomediche
City
Parma
Country
Italy
Facility Name
U.O Malattie Metaboliche e Diabetologia
City
Treviglio
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria
City
Trieste
Country
Italy
Facility Name
Volvat Medisinske Senter
City
Fredrikstad
Country
Norway
Facility Name
Nyomen Legekontor
City
Kongsberg
Country
Norway
Facility Name
Radhuset Spesialistsenter
City
Oslo
Country
Norway
Facility Name
Rikshospitalet - University Hospital
City
Oslo
Country
Norway
Facility Name
Skedsmo Medisinske Senter A.S.
City
Skedsmokorset
Country
Norway
Facility Name
Kemerovo Cardiology Dispensary
City
Kemerovo
Country
Russian Federation
Facility Name
Central Clinical Hospital 1 of RZD
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital 23
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital 64
City
Moscow
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital 68
City
Moscow
Country
Russian Federation
Facility Name
State Research Center for Preventive Medicine
City
Moscow
Country
Russian Federation
Facility Name
Novosibirsk Reg. Clinical Cardiology Dispensary
City
Novosibirsk
Country
Russian Federation
Facility Name
Central Medical Unit 122, St. Pb
City
Saint Petersburg
Country
Russian Federation
Facility Name
Clinical Hospital of Russian Academy of Sciences
City
Saint Petersburg
Country
Russian Federation
Facility Name
Consulting and Diagnostic Center 85
City
Saint Petersburg
Country
Russian Federation
Facility Name
Krestovsky Island Medical Institute
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pokrovskaya City Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
St Michael's Partnership
City
Bath
Country
United Kingdom
Facility Name
Avondale Surgery
City
Chesterfield
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
Country
United Kingdom
Facility Name
The Burngreave Surgery
City
Sheffield
Country
United Kingdom
Facility Name
St Helier Hospital
City
Surrey
Country
United Kingdom
Facility Name
Box Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
Eastleigh Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
Lovemead Group Practice
City
Wiltshire
Country
United Kingdom
Facility Name
St Chad's Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
The Health Centre
City
Wiltshire
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19785568
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. Erratum In: Curr Med Res Opin. 2010 May;26(5):1046. Dosage error in article text.
Results Reference
derived

Learn more about this trial

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

We'll reach out to this number within 24 hrs