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

January 25, 2010 updated by: Kowa Research Europe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • CCBR Aalborg
      • Vejle, Denmark
        • CCBR A/S
      • Vejle, Denmark
        • CCBR Vejle
  • Germany
      • Berlin-Spandau, Germany
        • Gemeinschaftspraxis am Bahnhof
      • Chemnitz, Germany
        • Pharmakologisches Studienzentum Chemnitz
      • Frankfurt Am Main, Germany
        • Internistische Diabetische Schwerpunktpraxis Dr.
      • Mainz, Germany
        • Internistische Gemeinschaftspraxis
      • Messkirch, Germany
        • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
  • India
      • Bangalore, India
        • Bhagwan Mahaveer Jain Heart Centre
      • Chennai, India
        • Sri Ramachandra Medical College Hospital
      • Hyderabaad, India
        • Apollo Hospitals
      • Hyderabaad, India
        • CARE Group of Hospitals
      • Mumbai, India
        • PD Hinduja Hospital
  • Netherlands
      • Breda, Netherlands
        • Andromed Breda
      • Eindhoven, Netherlands
        • Andromed Eindhoven
      • Groningen, Netherlands
        • Andromed Noord
      • Leiden, Netherlands
        • Andromed Leiden
      • Nijmegen, Netherlands
        • Andromed Nijmegen
      • Rotterdam, Netherlands
        • Andromed Rotterdam
      • Velp, Netherlands
        • Andromed Oost
      • Zoetermeer, Netherlands
        • Andromed Zoetermeer
  • Poland
      • Bialystok, Poland
        • Podlaski Ośrodek Kardiologii
      • Gruziadz, Poland
        • NZOZ GCP Dobra Praktyka Lekaska
      • Katowice, Poland
        • NZOZ Terapia Optima
      • Losice, Poland
        • NZOZ Esculap, Przychodnia Lekary Rodzinnych
      • Siedlce, Poland
        • NZOZ Centrum, Poradnia Kardiologiczna
      • Tarnow, Poland
        • Spec. Gab. Lek. Internistyczno-Kardiologicznly
      • Tychy, Poland
        • Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
      • Warszawa, Poland
        • Instytut Zywnosci i Zywienia
      • Warszawa, Poland
        • Lecznica PROSEN SMO
      • Warszawa, Poland
        • Szpital Wolski,im. Dr A. Gostynskiej
  • United Kingdom
      • Berkshire, United Kingdom
        • Synexus Reading Clinical Research Centre
      • Lancashire, United Kingdom
        • Synexus Lancashire Clinical Research Centre
      • Liverpool, United Kingdom
        • Synexus Merseyside Clinical Research Centre
      • Manchester, United Kingdom
        • Synexus Manchester Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type II diabetes mellitus
  • Combined dyslipidemia
  • Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

  • Withdrawal from NK-104-305 (NCT00309751)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin
Pitavastatin 4 mg QD
Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Names:
  • Livalo
Active Comparator: Atorvastatin
Atorvastatin 40 mg
Drug: Atorvastatin
Atorvastatin 40 mg
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NCEP LDL-C Target Attainment
Time Frame: 44 weeks
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.
44 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C
Time Frame: Basseline to 44 weeks
Percent change from baseline in LDL-C at 44 weeks
Basseline to 44 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Europe

Investigators

  • Study Director: Dragos Budinski, MD, Kowa Research Europe (KRE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 23, 2006

First Posted (Estimate)

June 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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