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NCT00309751 Clinical Trial

Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00309751
Other study ID # NK-104-305
Secondary ID
Status Completed
Phase Phase 3
First received December 8, 2005
Last updated February 17, 2010
Start date December 2005
Est. completion date June 2007

Study information
Verified date February 2010
Source Kowa Research Europe
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of HealthGermany: Ethics CommissionIndia: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 418
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Pitavastatin
Pitavastatin 4 mg QD
• Atorvastatin
Atorvastatin 20 mg

Locations
Country Name City State
Denmark CCBR Aalborg Aalborg
Denmark CCBR A/S Ballerup
Denmark CCBR Vejle Vejle
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
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
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
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
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

Sponsors (1)
Lead Sponsor Collaborator
Kowa Research Europe

Countries where clinical trial is conducted

Denmark,  Germany,  India,  Netherlands,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) 12 weeks No
Secondary Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target 12 weeks No
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