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Clinical Trial Details

Trial ID: L5426
Source ID: NCT00640549
Associated Drug: Atorvastatin
Title: Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
Acronym: ALPIN
Status: TERMINATED
Study Results: NO
Results:
Conditions: Hyperlipidemia|Diabetes Mellitus, Type 2|Non-Insulin Dependent Diabetes Mellitus
Interventions: DRUG: Atorvastatin|DRUG: Placebo
Outcome Measures: Primary: Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1), 8 weeks (visit 4)|Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1), 8 weeks (visit 4) | Secondary: Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1), 8 weeks (visit 4)|Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1), 8 weeks (visit 4)|Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1), 8 weeks (visit 4)|Changes in size of LDL subfractions compared with screening (visit 1), 8 weeks (visit 4)
Sponsor/Collaborators: Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2003-03
Completion Date: 2004-10
Results First Posted:
Last Update Posted: 2021-02-18
Locations: Pfizer Investigational Site, BAD Muenster AM Stein, 55583, Germany|Pfizer Investigational Site, Bosenheim, 55545, Germany|Pfizer Investigational Site, Bretten, 75015, Germany|Pfizer Investigational Site, Dresden, 01307, Germany|Pfizer Investigational Site, Duisburg, 47199, Germany|Pfizer Investigational Site, Essen, 45217, Germany|Pfizer Investigational Site, Goch, 47574, Germany|Pfizer Investigational Site, Heidelberg, 69120, Germany|Pfizer Investigational Site, Kuenzing, 94550, Germany|Pfizer Investigational Site, Offenbach, 63067, Germany|Pfizer Investigational Site, Offenbach, 63071, Germany|Pfizer Investigational Site, Offenbach, 63073, Germany|Pfizer Investigational Site, Rain, 94369, Germany|Pfizer Investigational Site, Schwabenheim, 55270, Germany
URL: https://clinicaltrials.gov/show/NCT00640549