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Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Primary Purpose

Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease

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, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia

Eligibility Criteria

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

Inclusion Criteria: Completed NK-104-304 (NCT 00309738) Hypercholesterolemia or combined dyslipidemia 2 or more risk factors for coronary heart disease (CHD) Exclusion Criteria: Withdrawn or terminated from NK-104-304 (00309738)

Sites / Locations

  • 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 Universitario Reina Sofia
  • Hospital Ramon y Cajal
  • Fundacion Jimenez Diaz
  • Hospital Clinico San Carlos
  • Hospital Clinico Universitario de Santiago
  • Angelholms Sjukhus, Medicinkliniken
  • Sahlgrenska University Hospital, Intermedicin
  • Hjartmottagningen
  • Lakarcentrum Nyponet
  • Medicinkliniken
  • 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

Simvastatin 40mg/80mg

Arm Description

Pitavastatin 4 mg once daily

Simvastatin 40 mg or 80 mg once daily

Outcomes

Primary Outcome Measures

Number of Patients Attaining NCEP LDL-C Target at Week 16
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Number of Patients Attaining NCEP LDL-C Target at Week 44
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.

Secondary Outcome Measures

Percent Change From Baseline in LDL-C

Full Information

First Posted
June 22, 2006
Last Updated
January 25, 2010
Sponsor
Kowa Research Europe
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1. Study Identification

Unique Protocol Identification Number
NCT00344175
Brief Title
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
Official Title
Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment 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
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Detailed Description
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease
Keywords
hypercholesterolemia, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Arm Title
Simvastatin 40mg/80mg
Arm Type
Active Comparator
Arm Description
Simvastatin 40 mg or 80 mg once daily
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Intervention Type
Drug
Intervention Name(s)
simvastatin
Primary Outcome Measure Information:
Title
Number of Patients Attaining NCEP LDL-C Target at Week 16
Description
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Time Frame
16 weeks
Title
Number of Patients Attaining NCEP LDL-C Target at Week 44
Description
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
Time Frame
44 Weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C
Time Frame
Baseline to 44 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed NK-104-304 (NCT 00309738) Hypercholesterolemia or combined dyslipidemia 2 or more risk factors for coronary heart disease (CHD) Exclusion Criteria: Withdrawn or terminated from NK-104-304 (00309738)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, MD
Organizational Affiliation
Kowa Research Europe
Official's Role
Study Director
Facility Information:
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 Universitario Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28000
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
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
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
21874537
Citation
Eriksson M, Budinski D, Hounslow N. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. Epub 2011 Aug 25.
Results Reference
derived

Learn more about this trial

Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

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