Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1902
Source ID: NCT00251680
Associated Drug: Lapaquistat Acetate And Lipid-Lowering Therapy
Title: Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Lapaquistat acetate and lipid-lowering therapy|DRUG: Lipid-lowering therapy
Outcome Measures: Primary: Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol, Week 24 or Final Visit | Secondary: Change from Baseline in Triglycerides, Week 24 or Final Visit|Change from Baseline in Total Cholesterol, Week 24 or Final Visit|Change from Baseline in High Density Lipoprotein cholesterol, Week 24 or Final Visit|Change from Baseline in Very Low Density Lipoprotein cholesterol, Week 24 or Final Visit|Change from Baseline in apolipoprotein A1, Week 24 or Final Visit|Change from Baseline in apolipoprotein B, Week 24 or Final Visit|Change from Baseline in non- High Density Lipoprotein cholesterol, Week 24 or Final Visit|Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol, Week 24 or Final Visit|Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol, Week 24 or Final Visit|Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B, Week 24 or Final Visit|Change from Baseline in high-sensitivity C-reactive protein, Week 24 or Final Visit|Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 1.81 mmol/L (70 mg/dL), Week 24 or Final Visit|Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL), Week 24 or Final Visit|Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL), Week 24 or Final Visit|Best corrected visual acuity, Week 24 or Final Visit|Adverse Events, Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit|Clinical Laboratory Tests, Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit|Vital Signs, Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit|12-lead Electrocardiogram, Weeks 12 and 24 or Final Visit|Physical Examination, Week 24 or Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2005-10
Completion Date: 2007-05
Results First Posted:
Last Update Posted: 2012-05-24
Locations: Tucson, Arizona, United States|Artesia, California, United States|Jacksonville, Florida, United States|Dunwoody, Georgia, United States|Idaho Falls, Idaho, United States|Aurora, Illinois, United States|Chicago, Illinois, United States|Melrose Park, Illinois, United States|Naperville, Illinois, United States|Overland Park, Kansas, United States|Livonia, Michigan, United States|Chesterfield, Missouri, United States|Margate, New Jersey, United States|Trenton, New Jersey, United States|Cincinnati, Ohio, United States|Bristol, Tennessee, United States|San Antonio, Texas, United States|Richmond, Virginia, United States|Benesov, Czech Republic|Holice v Cechach, Czech Republic|Kladno, Czech Republic|Mlada Boleslav, Czech Republic|Olomouc, Czech Republic|Praha, Czech Republic|Trutnov, Czech Republic|Usti nad Orlici, Czech Republic|Zlin, Czech Republic|Parnu, Estonia|Tallinn, Estonia|Tartu, Estonia|Helsinki, Finland|Hyvinkaa, Finland|Tampere, Finland|Turku, Finland|Berlin, Germany|Bochum, Germany|Chemnitz, Germany|Dresden, Germany|Frankfurt, Germany|Goerlitz, Germany|Leipzig, Germany|Nurnberg, Germany|Krakow, Poland|Leszno, Poland|Lublin, Poland|Niemodlin, Poland|Ostrowiec Swietokrzyski, Poland|Skierniewice, Poland|Sroda Wlkp, Poland|Starachowice, Poland|Warszawa, Poland|Zakopane, Poland|Banska Bystrica, Slovakia|Bojnice, Slovakia|Bratislava, Slovakia|Lucenec, Slovakia|Presov, Slovakia|Samorin, Slovakia|Zilina, Slovakia|Bloemfontein, South Africa|Cape Town, South Africa|Durban, South Africa|Lyttleton, South Africa|Pretoria, South Africa|Randburg, South Africa|Bath, United Kingdom|Birmingham, United Kingdom|Blackpool, United Kingdom|Blantyre, United Kingdom|Chippenham, United Kingdom|Edinburgh, United Kingdom|Glasgow, United Kingdom|Harrow, United Kingdom|Hinckley, United Kingdom|Newport, United Kingdom|NOttingham, United Kingdom|Woolpit, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00251680