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 Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin

Eligibility Criteria

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

Inclusion Criteria: Males and females (18-75 years of age) At least two cardiovascular disease risk factors Must have been following a restrictive diet Diagnosis of primary hypercholesterolemia or combined dyslipidemia Exclusion Criteria: Homozygous familial hypercholesterolemia Conditions which may cause secondary dyslipidemia Uncontrolled diabetes mellitus Abnormal pancreatic, liver or renal function Abnormal serum creatine kinase (CK) above the pre-specified level

Sites / Locations

  • CCBR A/S
  • CCBR A/S
  • Y Forskning, Bispebjerg Hospital
  • Frederiks Hospital, Kardiologisk
  • Kolesterollaboratoriet
  • CCBR A/S
  • Middellaan 5
  • Bomanshof 8
  • Damsterdiep 9
  • Doezastraat 1
  • Kamerlingh Onnesstraat 16-18
  • Mathenesserlaan 247
  • Reigerstraat 30
  • Parkdreef 142
  • Hospital Clinico S. Juan de Alicante
  • Hospital Clinic i Provincial
  • Hospital Universitario de Bellvitge
  • Hospital Vall d'Hebron
  • Hospital Universitario Reina Sofia
  • Fundacion Jimenez Diaz
  • Hospital Clinico San Carlos
  • Hospital Ramon y Cajal
  • Hospital Clinico Universitario de Santiago
  • Hospital de Sagunto
  • Angelholms Sjukhus, Medicinkliniken
  • Sahlgrenska University Hospital, Intermedicin
  • Hjartmottagningen
  • Lakarcentrum Nyponet
  • Medicinkliniken
  • Hjartmottagningen
  • Huslakaren i Sandviken
  • Narsjukhuset Sandviken, Kardiologlab, Medicin
  • Hjart & Karlcenter
  • Karolinska Universitetssjukhuset
  • Hjarthuset AB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pitavastatin 4 mg QD

Simvastatin 40 mg QD

Arm Description

Pitavastatin 4 mg once daily

Simvastatin 40 mg once daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures

Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)

Full Information

First Posted
December 8, 2005
Last Updated
March 9, 2010
Sponsor
Kowa Research Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT00309738
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 and 2 or More Risk Factors for Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 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 in patients with risk factors for heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg QD
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Arm Title
Simvastatin 40 mg QD
Arm Type
Active Comparator
Arm Description
Simvastatin 40 mg once daily
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Intervention Type
Drug
Intervention Name(s)
simvastatin
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C
Description
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Description
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)
Time Frame
12 weeks

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 of age) At least two cardiovascular disease risk factors Must have been following a restrictive diet Diagnosis of primary hypercholesterolemia or combined dyslipidemia Exclusion Criteria: Homozygous familial hypercholesterolemia Conditions which may cause secondary dyslipidemia Uncontrolled diabetes mellitus Abnormal pancreatic, liver or renal function Abnormal serum creatine kinase (CK) above the pre-specified level
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
CCBR A/S
City
Aalborg
Country
Denmark
Facility Name
CCBR A/S
City
Ballerup
Country
Denmark
Facility Name
Y Forskning, Bispebjerg Hospital
City
Copenhagen NV
Country
Denmark
Facility Name
Frederiks Hospital, Kardiologisk
City
Frederiksberg
Country
Denmark
Facility Name
Kolesterollaboratoriet
City
Hellerup
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
Country
Denmark
Facility Name
Middellaan 5
City
Breda
Country
Netherlands
Facility Name
Bomanshof 8
City
Eindhoven
Country
Netherlands
Facility Name
Damsterdiep 9
City
Groningen
Country
Netherlands
Facility Name
Doezastraat 1
City
Leiden
Country
Netherlands
Facility Name
Kamerlingh Onnesstraat 16-18
City
Nijmegen
Country
Netherlands
Facility Name
Mathenesserlaan 247
City
Rotterdam
Country
Netherlands
Facility Name
Reigerstraat 30
City
Velp
Country
Netherlands
Facility Name
Parkdreef 142
City
Zoetermeer
Country
Netherlands
Facility Name
Hospital Clinico S. Juan de Alicante
City
San Juan
State/Province
Alicante
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Villaroel
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital de Sagunto
City
Valencia
Country
Spain
Facility Name
Angelholms Sjukhus, Medicinkliniken
City
Angelhom
Country
Sweden
Facility Name
Sahlgrenska University Hospital, Intermedicin
City
Gothenburg
Country
Sweden
Facility Name
Hjartmottagningen
City
Helsingborg
Country
Sweden
Facility Name
Lakarcentrum Nyponet
City
Karineholm
Country
Sweden
Facility Name
Medicinkliniken
City
Ludvika
Country
Sweden
Facility Name
Hjartmottagningen
City
Malmo
Country
Sweden
Facility Name
Huslakaren i Sandviken
City
Sandviken
Country
Sweden
Facility Name
Narsjukhuset Sandviken, Kardiologlab, Medicin
City
Sandviken
Country
Sweden
Facility Name
Hjart & Karlcenter
City
Sodertalje
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
Country
Sweden
Facility Name
Hjarthuset AB
City
Varberg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21874538
Citation
Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.
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