Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT ID: NCT00309751
Last Updated: 2010-02-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
418 participants
INTERVENTIONAL
2005-12-31
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT00344370
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
NCT00309738
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
NCT00249249
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
NCT00309777
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
NCT00889226
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Pitavastatin
Pitavastatin 4 mg QD
Atorvastatin 20 mg QD
Atorvastatin 20 mg once daily
Atorvastatin
Atorvastatin 20 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pitavastatin
Pitavastatin 4 mg QD
Atorvastatin
Atorvastatin 20 mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kowa Research Europe
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kowa Research Europe
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dragos Budinski, Med Dr.
Role: STUDY_DIRECTOR
Kowa Research Europe
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CCBR Aalborg
Aalborg, , Denmark
CCBR A/S
Ballerup Municipality, , 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 Centrum, Poradnia Kardiologiczna
Siedlce, , Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly
Tarnów, , Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
Tychy, , Poland
Instytut Zywnosci i Zywienia
Warsaw, , Poland
Lecznica PROSEN SMO
Warsaw, , Poland
Szpital Wolski,im. Dr A. Gostynskiej
Warsaw, , Poland
NZOZ Esculap, Przychodnia Lekary Rodzinnych
Łosice, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NK-104-305
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.