DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study Comparing Pitavastatin and 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, Med Dr., Study Director, Affiliation: Kowa Research Europe

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.

Clinical Details

Official title: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) 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: Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)

Secondary outcome: Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

CCBR Aalborg, Aalborg, Denmark

CCBR A/S, Ballerup, 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: December 2005
Last updated: February 17, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017