Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia - Full Text View

Sponsor:	Kowa Research Europe
Information provided by:	Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00309751

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Atorvastatin Atorvastatin calcium Pitavastatin NK 104

U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:

Percent Change From Baseline LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients Attaining 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
Pitavastatin 4 mg QD: Experimental Pitavastatin 4 mg once daily	Drug: Pitavastatin Pitavastatin 4 mg QD
Atorvastatin 20 mg QD: Active Comparator Atorvastatin 20 mg once daily	Drug: Atorvastatin Atorvastatin 20 mg

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 a/S
Ballerup, Denmark
CCBR Vejle
Vejle, Denmark
CCBR Aalborg
Aalborg, Denmark
Germany
Pharmakologisches Studienzentum Chemnitz
Chemnitz, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
Messkirch, Germany
Internistische Diabetische Schwerpunktpraxis Dr.
Frankfurt Am Main, Germany
Internistische Gemeinschaftspraxis
Mainz, Germany
Gemeinschaftspraxis am Bahnhof
Berlin-Spandau, Germany
India
Bhagwan Mahaveer Jain Heart Centre
Bangalore, India
Sri Ramachandra Medical College Hospital
Chennai, India
PD Hinduja Hospital
Mumbai, India
Apollo Hospitals
Hyderabaad, India
CARE Group of Hospitals
Hyderabaad, India
Netherlands
Andromed Oost
Velp, Netherlands
Andromed Noord
Groningen, Netherlands
Andromed Zoetermeer
Zoetermeer, Netherlands
Andromed Rotterdam
Rotterdam, Netherlands
Andromed Leiden
Leiden, Netherlands
Andromed Nijmegen
Nijmegen, Netherlands
Andromed Breda
Breda, Netherlands
Andromed Eindhoven
Eindhoven, Netherlands
Poland
Instytut Zywnosci i Zywienia
Warszawa, Poland
Podlaski Osrodek Kardiologii
Bialystok, Poland
NZOZ Centrum, Poradnia Kardiologiczna
Siedlce, Poland
NZOZ Esculap, Przychodnia Lekary Rodzinnych
Losice, Poland
Szpital Wolski,im. Dr A. Gostynskiej
Warszawa, Poland
NZOZ GCP Dobra Praktyka Lekaska
Gruziadz, Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly
Tarnow, Poland
NZOZ Terapia Optima
Katowice, Poland
Lecznica PROSEN SMO
Warszawa, Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
Tychy, 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:	Kowa Research Europe ( Dragos Budinski, MD )
Study ID Numbers:	NK-104-305
Study First Received:	December 8, 2005
Results First Received:	August 26, 2009
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00309751 History of Changes
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:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
NK 104
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010