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

NCT ID: NCT00344370

Last Updated: 2010-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type II Diabetes Mellitus Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pitavastatin

Pitavastatin 4 mg QD

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

Pitavastatin 4 mg QD

Atorvastatin

Atorvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin 40 mg

Interventions

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Pitavastatin

Pitavastatin 4 mg QD

Intervention Type DRUG

Atorvastatin

Atorvastatin 40 mg

Intervention Type DRUG

Other Intervention Names

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Livalo Lipitor

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Withdrawal from NK-104-305 (NCT00309751)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowa Research Europe

INDUSTRY

Sponsor Role lead

Responsible Party

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Kowa Research Europe

Principal Investigators

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Dragos Budinski, MD

Role: STUDY_DIRECTOR

Kowa Research Europe (KRE)

Locations

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CCBR Aalborg

Aalborg, , Denmark

Site Status

CCBR A/S

Vejle, , Denmark

Site Status

CCBR Vejle

Vejle, , Denmark

Site Status

Gemeinschaftspraxis am Bahnhof

Berlin-Spandau, , Germany

Site Status

Pharmakologisches Studienzentum Chemnitz

Chemnitz, , Germany

Site Status

Internistische Diabetische Schwerpunktpraxis Dr.

Frankfurt am Main, , Germany

Site Status

Internistische Gemeinschaftspraxis

Mainz, , Germany

Site Status

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler

Messkirch, , Germany

Site Status

Bhagwan Mahaveer Jain Heart Centre

Bangalore, , India

Site Status

Sri Ramachandra Medical College Hospital

Chennai, , India

Site Status

Apollo Hospitals

Hyderabaad, , India

Site Status

CARE Group of Hospitals

Hyderabaad, , India

Site Status

PD Hinduja Hospital

Mumbai, , India

Site Status

Andromed Breda

Breda, , Netherlands

Site Status

Andromed Eindhoven

Eindhoven, , Netherlands

Site Status

Andromed Noord

Groningen, , Netherlands

Site Status

Andromed Leiden

Leiden, , Netherlands

Site Status

Andromed Nijmegen

Nijmegen, , Netherlands

Site Status

Andromed Rotterdam

Rotterdam, , Netherlands

Site Status

Andromed Oost

Velp, , Netherlands

Site Status

Andromed Zoetermeer

Zoetermeer, , Netherlands

Site Status

Podlaski Osrodek Kardiologii

Bialystok, , Poland

Site Status

NZOZ GCP Dobra Praktyka Lekaska

Gruziadz, , Poland

Site Status

NZOZ Terapia Optima

Katowice, , Poland

Site Status

NZOZ Centrum, Poradnia Kardiologiczna

Siedlce, , Poland

Site Status

Spec. Gab. Lek. Internistyczno-Kardiologicznly

Tarnów, , Poland

Site Status

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

Tychy, , Poland

Site Status

Instytut Zywnosci i Zywienia

Warsaw, , Poland

Site Status

Lecznica PROSEN SMO

Warsaw, , Poland

Site Status

Szpital Wolski,im. Dr A. Gostynskiej

Warsaw, , Poland

Site Status

NZOZ Esculap, Przychodnia Lekary Rodzinnych

Łosice, , Poland

Site Status

Synexus Reading Clinical Research Centre

Berkshire, , United Kingdom

Site Status

Synexus Lancashire Clinical Research Centre

Lancashire, , United Kingdom

Site Status

Synexus Merseyside Clinical Research Centre

Liverpool, , United Kingdom

Site Status

Synexus Manchester Clinical Research Centre

Manchester, , United Kingdom

Site Status

Countries

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Denmark Germany India Netherlands Poland United Kingdom

Other Identifiers

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NK-104-310

Identifier Type: -

Identifier Source: org_study_id

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