Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6699
Source ID: NCT04882293
Associated Drug: Atorvastatin 20 Mg / Fenofibrate 160 Mg In Fixed Dose
Title: Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
Interventions: DRUG: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose|DRUG: Atorvastatin (Lipitor ®)
Outcome Measures: Primary: Magnitude of change in lipid profile figures., To assess the magnitude of change in lipid profile figures (Lp \[a\], LDL, and triglycerides) at 2 and 4 months with respect to their baseline measurement and between treatment groups., Baseline, 2 and 4 months.|Proportion of subjects achieving triglyceride levels <150 mg /dL., Describe the proportion of subjects who achieved triglyceride levels \<150 mg / dL at the end of treatment., 4 months|Describe the proportion of subjects who reduced levels of LDL cholesterol, Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value., Baseline and 4 months. | Secondary: Impact on anthropometric indicators (Weight), Describe changes in weight (kg) measurements from baseline to the end of the study (4 months)., Baseline and 4 Months|Impact on anthropometric indicators body mass index (BMI), Describe changes in BMI (kg/m2) from baseline to the end of the study (4 months), Baseline and 4 months|Impact on anthropometric indicators (Waist circumference), Describe changes in waist circumference (cm) from baseline to the end of the study (4 months)., Baseline and 4 months|Impact on liver function with aspartate aminotransferas (AST), Describe the changes in AST (mg/dL) concentration, between baseline and the end of the study., Baseline and 4 months|Impact on liver function with Alanine Aminotransferase (ALT), Describe the changes in ALT (mg/dL) concentration, between baseline and the end of the study., Baseline and 4 months|Impact on Glycosylated hemoglobin (HbA1c), Describe the changes in HbA1c percentage from baseline to the end of the study (4 months)., Baseline and 4 months|Impact on glucose levels, Describe the changes in glucose levels (mg/dL) from baseline to the end of the study (4 months)., Baseline and 4 months|Impact on Blood pressure, Describe the changes in blood pressure (mm Hg) from baseline to the end of the study (4 months). impact on clinical indicators (Blood pressure, Heart rate, Respiratory rate)., Baseline and 4 months|Impact on heart rate, Describe the changes in heart rate (beats per minute) from baseline to the end of the study (4 months)., Baseline and 4 months|Impact on respiratory rate, Describe the changes in respiratory rate (Pulses per minute) from baseline to the end of the study (4 months)., Baseline and 4 months|Events and adverse reactions presented., Proportion of events and adverse reactions presented during 4 months of treatment., 4 months
Sponsor/Collaborators: Sponsor: Laboratorios Silanes S.A. de C.V.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 78
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-15
Completion Date: 2022-05
Results First Posted:
Last Update Posted: 2022-03-02
Locations: Laboratorio Silanes, S.A. de C.V., Mexico City, 11000, Mexico
URL: https://clinicaltrials.gov/show/NCT04882293