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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00344370
First received: June 23, 2006
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
Dyslipidemia
Drug: Pitavastatin
Drug: Atorvastatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • NCEP LDL-C Target Attainment [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 weeks ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin
Pitavastatin 4 mg QD
Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Name: Livalo
Active Comparator: Atorvastatin
Atorvastatin 40 mg
Drug: Atorvastatin
Atorvastatin 40 mg
Other Name: Lipitor

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Withdrawal from NK-104-305 (NCT00309751)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344370

Locations
Denmark
CCBR Aalborg
Aalborg, Denmark
CCBR A/S
Vejle, Denmark
CCBR Vejle
Vejle, Denmark
Germany
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
India
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
Netherlands
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
Poland
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
United Kingdom
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
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, MD Kowa Research Europe (KRE)
  More Information

No publications provided

Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00344370     History of Changes
Other Study ID Numbers: NK-104-310
Study First Received: June 23, 2006
Results First Received: September 1, 2009
Last Updated: January 25, 2010
Health Authority: Poland: Ministry of Health
Germany: Ethics Commission
India: Indian Council of Medical Research

Keywords provided by Kowa Research Europe:
Pitavastatin
Type II Diabetes Mellitus
Combined Dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014