NCT00344370

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2006

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

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

June 23, 2006

Results QC Date

September 1, 2009

Last Update Submit

January 25, 2010

Conditions

Type II Diabetes MellitusDyslipidemia

Keywords

PitavastatinType II Diabetes MellitusCombined Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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.

    44 weeks

Secondary Outcomes (1)

  • Percent Change From Baseline in LDL-C

    Basseline to 44 weeks

Study Arms (2)

Pitavastatin

EXPERIMENTAL

Pitavastatin 4 mg QD

Drug: Pitavastatin

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 40 mg

Drug: Atorvastatin

Interventions

PitavastatinDRUG

Pitavastatin 4 mg QD

Also known as: Livalo
Pitavastatin
AtorvastatinDRUG

Atorvastatin 40 mg

Also known as: Lipitor
Atorvastatin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Withdrawal from NK-104-305 (NCT00309751)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

CCBR Aalborg

Aalborg, Denmark

Location

CCBR A/S

Vejle, 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
barana@kowaus.com
919 433-1600

Study Officials

  • Dragos Budinski, MD

    Kowa Research Europe (KRE)

    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

June 23, 2006

First Posted

June 26, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 2, 2010

Results First Posted

January 18, 2010

Record last verified: 2010-01

Locations

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