Clinical trial NCT00309751: Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Official title: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type II Diabetes Mellitus
Dyslipidemia
Keywords: Kowa
Type II Diabetes Mellitus
Combined Dyslipidemia
pitavastatin
NK-104
Atorvastatin
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR Aalborg
city: Ballerup
country: Denmark
facility: CCBR A/S
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Berlin-Spandau
country: Germany
facility: Gemeinschaftspraxis am Bahnhof
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentum Chemnitz
city: Frankfurt Am Main
country: Germany
facility: Internistische Diabetische Schwerpunktpraxis Dr.
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Messkirch
country: Germany
facility: Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Heart Centre
city: Chennai
country: India
facility: Sri Ramachandra Medical College Hospital
city: Hyderabaad
country: India
facility: Apollo Hospitals
city: Hyderabaad
country: India
facility: CARE Group of Hospitals
city: Mumbai
country: India
facility: PD Hinduja Hospital
city: Breda
country: Netherlands
facility: Andromed Breda
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Nijmegen
country: Netherlands
facility: Andromed Nijmegen
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Bialystok
country: Poland
facility: Podlaski Osrodek Kardiologii
city: Gruziadz
country: Poland
facility: NZOZ GCP Dobra Praktyka Lekaska
city: Katowice
country: Poland
facility: NZOZ Terapia Optima
city: Losice
country: Poland
facility: NZOZ Esculap, Przychodnia Lekary Rodzinnych
city: Siedlce
country: Poland
facility: NZOZ Centrum, Poradnia Kardiologiczna
city: Tarnow
country: Poland
facility: Spec. Gab. Lek. Internistyczno-Kardiologicznly
city: Tychy
country: Poland
facility: Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
city: Warszawa
country: Poland
facility: Instytut Zywnosci i Zywienia
city: Warszawa
country: Poland
facility: Lecznica PROSEN SMO
city: Warszawa
country: Poland
facility: Szpital Wolski,im. Dr A. Gostynskiej
city: Berkshire
country: United Kingdom
facility: Synexus Reading Clinical Research Centre
city: Lancashire
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
Study officials:
affiliation: Kowa Research Europe
name: Dragos Budinski, Med Dr.
role: STUDY_DIRECTOR
References: