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

February 17, 2010 updated by: Kowa Research Europe

Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

418

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
      • Ballerup, 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg QD
Active Comparator: Atorvastatin 20 mg QD
Atorvastatin 20 mg once daily
Drug: Atorvastatin
Atorvastatin 20 mg
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: 12 weeks
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Time Frame: 12 weeks
Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks
12 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, Med Dr., Kowa Research Europe

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

December 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

February 23, 2010

Last Update Submitted That Met QC Criteria

February 17, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-305

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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