search
Back to results

Study Comparing Pitavastatin and 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 Kowa, Type II Diabetes Mellitus, Combined Dyslipidemia, pitavastatin, NK-104, Atorvastatin

Eligibility Criteria

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

Inclusion Criteria: Males and females (ages 18-75 years) Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy) Must have been following a restrictive diet Diagnosis of 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 Significant heart disease

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 4 mg QD

Atorvastatin 20 mg QD

Arm Description

Pitavastatin 4 mg once daily

Atorvastatin 20 mg once daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Full Information

First Posted
December 8, 2005
Last Updated
February 17, 2010
Sponsor
Kowa Research Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT00309751
Brief Title
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Official Title
Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (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 atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

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
Kowa, Type II Diabetes Mellitus, Combined Dyslipidemia, pitavastatin, NK-104, Atorvastatin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg QD
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Arm Title
Atorvastatin 20 mg QD
Arm Type
Active Comparator
Arm Description
Atorvastatin 20 mg once daily
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin 4 mg QD
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin 20 mg
Primary Outcome Measure Information:
Title
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Description
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Description
Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks
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 (ages 18-75 years) Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy) Must have been following a restrictive diet Diagnosis of 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 Significant heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, Med Dr.
Organizational Affiliation
Kowa Research Europe
Official's Role
Study Director
Facility Information:
Facility Name
CCBR Aalborg
City
Aalborg
Country
Denmark
Facility Name
CCBR A/S
City
Ballerup
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

Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

We'll reach out to this number within 24 hrs