NCT00309751

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
6 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

December 8, 2005

Results QC Date

August 26, 2009

Last Update Submit

February 17, 2010

Conditions

Type II Diabetes MellitusDyslipidemia

Keywords

KowaType II Diabetes MellitusCombined DyslipidemiapitavastatinNK-104Atorvastatin

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)

    Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

    12 weeks

Secondary Outcomes (1)

  • Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target

    12 weeks

Study Arms (2)

Pitavastatin 4 mg QD

EXPERIMENTAL

Pitavastatin 4 mg once daily

Drug: Pitavastatin

Atorvastatin 20 mg QD

ACTIVE COMPARATOR

Atorvastatin 20 mg once daily

Drug: Atorvastatin

Interventions

PitavastatinDRUG

Pitavastatin 4 mg QD

Pitavastatin 4 mg QD
AtorvastatinDRUG

Atorvastatin 20 mg

Also known as: Lipitor
Atorvastatin 20 mg QD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

CCBR Aalborg

Aalborg, Denmark

Location

CCBR A/S

Ballerup Municipality, Denmark

Location

CCBR Vejle

Vejle, Denmark

Location

Gemeinschaftspraxis am Bahnhof

Berlin-Spandau, Germany

Location

Pharmakologisches Studienzentum Chemnitz

Chemnitz, Germany

Location

Internistische Diabetische Schwerpunktpraxis Dr.

Frankfurt am Main, Germany

Location

Internistische Gemeinschaftspraxis

Mainz, Germany

Location

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler

Messkirch, Germany

Location

Bhagwan Mahaveer Jain Heart Centre

Bangalore, India

Location

Sri Ramachandra Medical College Hospital

Chennai, India

Location

Apollo Hospitals

Hyderabaad, India

Location

CARE Group of Hospitals

Hyderabaad, India

Location

PD Hinduja Hospital

Mumbai, India

Location

Andromed Breda

Breda, Netherlands

Location

Andromed Eindhoven

Eindhoven, Netherlands

Location

Andromed Noord

Groningen, Netherlands

Location

Andromed Leiden

Leiden, Netherlands

Location

Andromed Nijmegen

Nijmegen, Netherlands

Location

Andromed Rotterdam

Rotterdam, Netherlands

Location

Andromed Oost

Velp, Netherlands

Location

Andromed Zoetermeer

Zoetermeer, Netherlands

Location

Podlaski Osrodek Kardiologii

Bialystok, Poland

Location

NZOZ GCP Dobra Praktyka Lekaska

Gruziadz, Poland

Location

NZOZ Terapia Optima

Katowice, Poland

Location

NZOZ Centrum, Poradnia Kardiologiczna

Siedlce, Poland

Location

Spec. Gab. Lek. Internistyczno-Kardiologicznly

Tarnów, Poland

Location

Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego

Tychy, Poland

Location

Instytut Zywnosci i Zywienia

Warsaw, Poland

Location

Lecznica PROSEN SMO

Warsaw, Poland

Location

Szpital Wolski,im. Dr A. Gostynskiej

Warsaw, Poland

Location

NZOZ Esculap, Przychodnia Lekary Rodzinnych

Łosice, Poland

Location

Synexus Reading Clinical Research Centre

Berkshire, United Kingdom

Location

Synexus Lancashire Clinical Research Centre

Lancashire, United Kingdom

Location

Synexus Merseyside Clinical Research Centre

Liverpool, United Kingdom

Location

Synexus Manchester Clinical Research Centre

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Interventions

pitavastatinAtorvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Bill Arana
Organization
Kowa Research Institute Inc
barana@kowaus.com
919 433 1600

Study Officials

  • Dragos Budinski, Med Dr.

    Kowa Research Europe

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2005

First Posted

April 3, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 23, 2010

Results First Posted

January 18, 2010

Record last verified: 2010-02

Locations

PL(10)GB(4)NL(8)IN(5)DK(3)DE(5)