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Clinical Trial Details

Trial ID: L5386
Source ID: NCT02842359
Associated Drug: Irbesartan/Atorvastatin Fixed Dose Combination
Title: Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Irbesartan/atorvastatin fixed dose combination|DRUG: Irbesartan SR47436|DRUG: Atorvastatin
Outcome Measures: Primary: Change from baseline in flow mediated dilatation, 4 weeks, up to maximum 5 weeks | Secondary: Rate of change from baseline in nytrotyrosine marker, 4 weeks, up to maximum 5 weeks|Rate of change from baseline in Intercellular Adhesion Molecule-1, 4 weeks, up to maximum 5 weeks|Rate of change from baseline in Interleukin-6, 4 weeks, up to maximum 5 weeks|Rate of change from baseline in C-reactive protein, 4 weeks, up to maximum 5 weeks|Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group), 4 weeks, up to maximum 5 weeks|Change from baseline in low density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group), 4 weeks, up to maximum 5 weeks|Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group), 4 weeks, up to maximum 5 weeks|Change from baseline in high density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group), 4 weeks, up to maximum 5 weeks|Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group), 4 weeks, up to maximum 5 weeks|Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group), 4 weeks, up to maximum 5 weeks|Change from baseline in apolipoprotein-B (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group) - Time Frame: 4 weeks, up to maximum 5 weeks, 4 weeks, up to maximum 5 weeks|Percentage of participants with decreased level of blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group), 4 weeks, up to maximum 5 weeks|Rate of change from baseline in immunosenescence T cell fractionation, 4 weeks, up to maximum 5 weeks|Rate of change from baseline in T-cell induced inflammatory factors, 4 weeks, up to maximum 5 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-08-23
Completion Date: 2018-04-19
Results First Posted:
Last Update Posted: 2022-04-13
Locations: Korea, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02842359