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

Information source: Kowa Research Europe
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type II Diabetes Mellitus; Dyslipidemia

Intervention: Pitavastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kowa Research Europe

Official(s) and/or principal investigator(s):
Dragos Budinski, MD, Study Director, Affiliation: Kowa Research Europe (KRE)

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.

Clinical Details

Official title: Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: NCEP LDL-C Target Attainment

Secondary outcome: Percent Change From Baseline in LDL-C

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type II diabetes mellitus

- Combined dyslipidemia

- Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

- Withdrawal from NK-104-305 (NCT00309751)

Locations and Contacts

CCBR Aalborg, Aalborg, Denmark

CCBR A/S, Vejle, Denmark

CCBR Vejle, Vejle, Denmark

Gemeinschaftspraxis am Bahnhof, Berlin-Spandau, Germany

Pharmakologisches Studienzentum Chemnitz, Chemnitz, Germany

Internistische Diabetische Schwerpunktpraxis Dr., Frankfurt Am Main, Germany

Internistische Gemeinschaftspraxis, Mainz, Germany

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler, Messkirch, Germany

Bhagwan Mahaveer Jain Heart Centre, Bangalore, India

Sri Ramachandra Medical College Hospital, Chennai, India

Apollo Hospitals, Hyderabaad, India

CARE Group of Hospitals, Hyderabaad, India

PD Hinduja Hospital, Mumbai, India

Andromed Breda, Breda, Netherlands

Andromed Eindhoven, Eindhoven, Netherlands

Andromed Noord, Groningen, Netherlands

Andromed Leiden, Leiden, Netherlands

Andromed Nijmegen, Nijmegen, Netherlands

Andromed Rotterdam, Rotterdam, Netherlands

Andromed Oost, Velp, Netherlands

Andromed Zoetermeer, Zoetermeer, Netherlands

Podlaski Osrodek Kardiologii, Bialystok, Poland

NZOZ GCP Dobra Praktyka Lekaska, Gruziadz, Poland

NZOZ Terapia Optima, Katowice, Poland

NZOZ Esculap, Przychodnia Lekary Rodzinnych, Losice, 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

Lecznica PROSEN SMO, Warszawa, Poland

Szpital Wolski,im. Dr A. Gostynskiej, Warszawa, Poland

Synexus Reading Clinical Research Centre, Berkshire, United Kingdom

Synexus Lancashire Clinical Research Centre, Lancashire, United Kingdom

Synexus Merseyside Clinical Research Centre, Liverpool, United Kingdom

Synexus Manchester Clinical Research Centre, Manchester, United Kingdom

Additional Information

Starting date: August 2006
Last updated: January 25, 2010

Page last updated: August 23, 2015

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