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Clinical Trial Details

Trial ID: L6675
Source ID: NCT02015988
Associated Drug: Fenofibrate
Title: Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Acute Coronary Syndrome|Diabetes Mellitus, Type 2|Hypertriglyceridemia
Interventions: DRUG: Fenofibrate|DRUG: Simvastatin
Outcome Measures: Primary: Percentage change from baseline in triglycerides (TG) at week 12, Baseline, Week 12 | Secondary: Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12, Week 12|Percentage changes from baseline in apoB/apoA1 ratio at week 12, Baseline, Week 12|Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12, Baseline, Week 12|Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12, Baseline, Week 12|Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12, Baseline, Week 12|Percentage changes from baseline in uric acid at week 12, Baseline, Week 12|Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52, Week 52|Percentage changes from baseline in apoB/apoA1 ratio at week 52, Baseline, Week 52|Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52, Baseline, Week 52|Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52, Baseline, Week 52|Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52, Baseline, Week 52|Percentage changes from baseline in uric acid at week 52, Baseline, Week 52 | Other: Number of adverse events (AE) caused discontinuations of investigational products, Up to 52 week
Sponsor/Collaborators: Sponsor: Koval' O., MD
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01
Completion Date: 2017-05
Results First Posted:
Last Update Posted: 2016-08-04
Locations: State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine", Dnipropetrovsk, Ukraine
URL: https://clinicaltrials.gov/show/NCT02015988