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Clinical Trial Details

Trial ID: L5806
Source ID: NCT00344370
Associated Drug: Pitavastatin
Title: Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00344370/results
Conditions: Type II Diabetes Mellitus|Dyslipidemia
Interventions: DRUG: Pitavastatin|DRUG: Atorvastatin
Outcome Measures: Primary: NCEP LDL-C Target Attainment, Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study., 44 weeks | Secondary: Percent Change From Baseline in LDL-C, Percent change from baseline in LDL-C at 44 weeks, Basseline to 44 weeks
Sponsor/Collaborators: Sponsor: Kowa Research Europe
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 214
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-08
Completion Date: 2008-04
Results First Posted: 2010-01-18
Last Update Posted: 2010-02-02
Locations: CCBR Aalborg, Aalborg, Denmark|CCBR A/S, Vejle, 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
URL: https://clinicaltrials.gov/show/NCT00344370

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D474 Pitavastatin small molecule DB08860 Details
D320 Atorvastatin small molecule DB01076 Details