Clinical trial NCT00344370: Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Official title: Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, 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: Pitavastatin
Type II Diabetes Mellitus
Combined Dyslipidemia
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-06-26
Enrollment: 214
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.


Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus
* Combined dyslipidemia
* Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

* Withdrawal from NK-104-305 (NCT00309751)

Primary outcomes:
measure: NCEP LDL-C Target Attainment
timeFrame: 44 weeks
Secondary outcomes:
measure: Percent Change From Baseline in LDL-C
timeFrame: Basseline to 44 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR Aalborg
city: Vejle
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 (KRE)
name: Dragos Budinski, MD
role: STUDY_DIRECTOR
References: