search
Back to results

Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Primary Purpose

Type II Diabetes Mellitus, Dyslipidemia

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

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Pitavastatin, Type II Diabetes Mellitus, Combined Dyslipidemia

Eligibility Criteria

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

Inclusion Criteria: Type II diabetes mellitus Combined dyslipidemia Completed NK-104-305 (NCT00309751) Exclusion Criteria: Withdrawal from NK-104-305 (NCT00309751)

Sites / Locations

  • CCBR Aalborg
  • CCBR A/S
  • CCBR Vejle
  • Gemeinschaftspraxis am Bahnhof
  • Pharmakologisches Studienzentum Chemnitz
  • Internistische Diabetische Schwerpunktpraxis Dr.
  • Internistische Gemeinschaftspraxis
  • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
  • Bhagwan Mahaveer Jain Heart Centre
  • Sri Ramachandra Medical College Hospital
  • Apollo Hospitals
  • CARE Group of Hospitals
  • PD Hinduja Hospital
  • Andromed Breda
  • Andromed Eindhoven
  • Andromed Noord
  • Andromed Leiden
  • Andromed Nijmegen
  • Andromed Rotterdam
  • Andromed Oost
  • Andromed Zoetermeer
  • Podlaski Osrodek Kardiologii
  • NZOZ GCP Dobra Praktyka Lekaska
  • NZOZ Terapia Optima
  • NZOZ Esculap, Przychodnia Lekary Rodzinnych
  • NZOZ Centrum, Poradnia Kardiologiczna
  • Spec. Gab. Lek. Internistyczno-Kardiologicznly
  • Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
  • Instytut Zywnosci i Zywienia
  • Lecznica PROSEN SMO
  • Szpital Wolski,im. Dr A. Gostynskiej
  • Synexus Reading Clinical Research Centre
  • Synexus Lancashire Clinical Research Centre
  • Synexus Merseyside Clinical Research Centre
  • Synexus Manchester Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pitavastatin

Atorvastatin

Arm Description

Pitavastatin 4 mg QD

Atorvastatin 40 mg

Outcomes

Primary Outcome Measures

NCEP LDL-C Target Attainment
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.

Secondary Outcome Measures

Percent Change From Baseline in LDL-C
Percent change from baseline in LDL-C at 44 weeks

Full Information

First Posted
June 23, 2006
Last Updated
January 25, 2010
Sponsor
Kowa Research Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT00344370
Brief Title
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Official Title
Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (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 double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus, Dyslipidemia
Keywords
Pitavastatin, Type II Diabetes Mellitus, Combined Dyslipidemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg QD
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Other Intervention Name(s)
Livalo
Intervention Description
Pitavastatin 4 mg QD
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin 40 mg
Primary Outcome Measure Information:
Title
NCEP LDL-C Target Attainment
Description
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
Time Frame
44 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C
Description
Percent change from baseline in LDL-C at 44 weeks
Time Frame
Basseline to 44 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type II diabetes mellitus Combined dyslipidemia Completed NK-104-305 (NCT00309751) Exclusion Criteria: Withdrawal from NK-104-305 (NCT00309751)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, MD
Organizational Affiliation
Kowa Research Europe (KRE)
Official's Role
Study Director
Facility Information:
Facility Name
CCBR Aalborg
City
Aalborg
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
Country
Denmark
Facility Name
CCBR Vejle
City
Vejle
Country
Denmark
Facility Name
Gemeinschaftspraxis am Bahnhof
City
Berlin-Spandau
Country
Germany
Facility Name
Pharmakologisches Studienzentum Chemnitz
City
Chemnitz
Country
Germany
Facility Name
Internistische Diabetische Schwerpunktpraxis Dr.
City
Frankfurt Am Main
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Mainz
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
City
Messkirch
Country
Germany
Facility Name
Bhagwan Mahaveer Jain Heart Centre
City
Bangalore
Country
India
Facility Name
Sri Ramachandra Medical College Hospital
City
Chennai
Country
India
Facility Name
Apollo Hospitals
City
Hyderabaad
Country
India
Facility Name
CARE Group of Hospitals
City
Hyderabaad
Country
India
Facility Name
PD Hinduja Hospital
City
Mumbai
Country
India
Facility Name
Andromed Breda
City
Breda
Country
Netherlands
Facility Name
Andromed Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Andromed Noord
City
Groningen
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiden
Country
Netherlands
Facility Name
Andromed Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Zoetermeer
Country
Netherlands
Facility Name
Podlaski Osrodek Kardiologii
City
Bialystok
Country
Poland
Facility Name
NZOZ GCP Dobra Praktyka Lekaska
City
Gruziadz
Country
Poland
Facility Name
NZOZ Terapia Optima
City
Katowice
Country
Poland
Facility Name
NZOZ Esculap, Przychodnia Lekary Rodzinnych
City
Losice
Country
Poland
Facility Name
NZOZ Centrum, Poradnia Kardiologiczna
City
Siedlce
Country
Poland
Facility Name
Spec. Gab. Lek. Internistyczno-Kardiologicznly
City
Tarnow
Country
Poland
Facility Name
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
City
Tychy
Country
Poland
Facility Name
Instytut Zywnosci i Zywienia
City
Warszawa
Country
Poland
Facility Name
Lecznica PROSEN SMO
City
Warszawa
Country
Poland
Facility Name
Szpital Wolski,im. Dr A. Gostynskiej
City
Warszawa
Country
Poland
Facility Name
Synexus Reading Clinical Research Centre
City
Berkshire
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Centre
City
Lancashire
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

We'll reach out to this number within 24 hrs