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

Phase 3

Completed

• Conditions: Type II Diabetes Mellitus; Dyslipidemia
• Interventions: Drug: Pitavastatin; Drug: Atorvastatin

• Registration Number: NCT00344370
• Lead Sponsor: Kowa Research Europe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-23
• Study First Submitted QC: 2006-06-23
• Study First Posted: 2006-06-26
• Study Start: 2006-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-09-01
• Results First Submitted QC: 2009-12-11
• Status Verified: 2010-01
• Results First Posted: 2010-01-18
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

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

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Exclusion Criteria

• Withdrawal from NK-104-305 (NCT00309751)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin	Pitavastatin	Pitavastatin 4 mg QD
Atorvastatin	Atorvastatin	Atorvastatin 40 mg

Primary Outcome Measures

Name	Time	Method
NCEP LDL-C Target Attainment	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C	Basseline to 44 weeks	Percent change from baseline in LDL-C at 44 weeks

Trial Locations

Locations (35)

Sri Ramachandra Medical College Hospital; 🇮🇳 Chennai, India

Apollo Hospitals; 🇮🇳 Hyderabaad, India

Szpital Wolski,im. Dr A. Gostynskiej; 🇵🇱 Warszawa, Poland

PD Hinduja Hospital; 🇮🇳 Mumbai, India

NZOZ GCP Dobra Praktyka Lekaska; 🇵🇱 Gruziadz, Poland

NZOZ Terapia Optima; 🇵🇱 Katowice, Poland

NZOZ Centrum, Poradnia Kardiologiczna; 🇵🇱 Siedlce, Poland

Spec. Gab. Lek. Internistyczno-Kardiologicznly; 🇵🇱 Tarnow, Poland

Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego; 🇵🇱 Tychy, Poland

Instytut Zywnosci i Zywienia; 🇵🇱 Warszawa, Poland

Gemeinschaftspraxis am Bahnhof; 🇩🇪 Berlin-Spandau, Germany

Pharmakologisches Studienzentum Chemnitz; 🇩🇪 Chemnitz, Germany

CCBR Aalborg; 🇩🇰 Aalborg, Denmark

CCBR Vejle; 🇩🇰 Vejle, Denmark

CCBR A/S; 🇩🇰 Vejle, Denmark

Internistische Diabetische Schwerpunktpraxis Dr.; 🇩🇪 Frankfurt Am Main, Germany

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler; 🇩🇪 Messkirch, Germany

Bhagwan Mahaveer Jain Heart Centre; 🇮🇳 Bangalore, India

CARE Group of Hospitals; 🇮🇳 Hyderabaad, India

Andromed Eindhoven; 🇳🇱 Eindhoven, Netherlands

Andromed Noord; 🇳🇱 Groningen, Netherlands

Andromed Oost; 🇳🇱 Velp, Netherlands

Andromed Breda; 🇳🇱 Breda, Netherlands

Andromed Leiden; 🇳🇱 Leiden, Netherlands

Andromed Rotterdam; 🇳🇱 Rotterdam, Netherlands

Andromed Zoetermeer; 🇳🇱 Zoetermeer, Netherlands

Podlaski Osrodek Kardiologii; 🇵🇱 Bialystok, Poland

Andromed Nijmegen; 🇳🇱 Nijmegen, Netherlands

NZOZ Esculap, Przychodnia Lekary Rodzinnych; 🇵🇱 Losice, Poland

Lecznica PROSEN SMO; 🇵🇱 Warszawa, Poland

Synexus Reading Clinical Research Centre; 🇬🇧 Berkshire, United Kingdom

Synexus Manchester Clinical Research Centre; 🇬🇧 Manchester, United Kingdom

Synexus Merseyside Clinical Research Centre; 🇬🇧 Liverpool, United Kingdom

Synexus Lancashire Clinical Research Centre; 🇬🇧 Lancashire, United Kingdom

Internistische Gemeinschaftspraxis; 🇩🇪 Mainz, Germany