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Study Comparing Pitavastatin and 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:
NCT00309751
First received: December 8, 2005
Last updated: February 17, 2010
Last verified: February 2010
History of Changes
  Purpose

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.


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: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: December 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
 Drug: Pitavastatin
Pitavastatin 4 mg QD
Active Comparator: Atorvastatin 20 mg QD
Atorvastatin 20 mg once daily
 Drug: Atorvastatin
Atorvastatin 20 mg
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females (ages 18-75 years)
  • Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
  • Must have been following a restrictive diet
  • Diagnosis of combined dyslipidemia

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia
  • Conditions which may cause secondary dyslipidemia
  • Uncontrolled diabetes mellitus
  • Abnormal pancreatic, liver, or renal function
  • Abnormal serum creatine kinase (CK) above the pre-specified level
  • Significant heart disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309751

Locations
Denmark
CCBR Aalborg
Aalborg, Denmark
CCBR A/S
Ballerup, 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
CARE Group of Hospitals
Hyderabaad, India
Apollo 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
Szpital Wolski,im. Dr A. Gostynskiej
Warszawa, Poland
Lecznica PROSEN SMO
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, Med Dr. Kowa Research Europe
  More Information

No publications provided

Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309751     History of Changes
Other Study ID Numbers: NK-104-305
Study First Received: December 8, 2005
Results First Received: August 26, 2009
Last Updated: February 17, 2010
Health Authority: Poland: Ministry of Health
Germany: Ethics Commission
India: Indian Council of Medical Research

Keywords provided by Kowa Research Europe:
Kowa
Type II Diabetes Mellitus
Combined Dyslipidemia
 pitavastatin
NK-104
Atorvastatin

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

ClinicalTrials.gov processed this record on June 18, 2013