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Clinical Trial Details

Trial ID: L0108
Source ID: NCT03543774
Associated Drug: Simvastatin 40mg
Title: Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population
Acronym: VietCKD
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Hypercholesterolemia|Chronic Kidney Diseases
Interventions: DRUG: Simvastatin 40mg|DRUG: Ezetimibe/simvastatin 10/20 mg/day|DRUG: Ezetimibe/simvastatin 10/40 mg/day
Outcome Measures: Primary: To measure the serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin in Vietnamese CKD population and in healthy persons at the base time., The serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin will be measured in mg/dL., At the base time|To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population and in healthy persons at the base time., The serum level of Taurine, Tryp, and Kyn will be measured in micromol/L, At the base time|To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population and in healthy persons at the base time., The number of red blood cell, white blood cell, and platelet will be measured in number/L, At the base time|To measure the serum level of MDA in Vietnamese CKD population and in healthy persons at the base time., The serum level of MDA will be measured in nmol/L, At the base time|To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population and in healthy persons at the base time., The serum level of Albuminuria and urine Creatinine will be measured in mg/dL, At the base time|To measure the serum level of SGOT, SGPT, and Creatinin Kinase in Vietnamese CKD population and in healthy persons at the base time., The serum level of SGOT, SGPT and Creatinin Kinase will be measured in Units/L, At the base time | Secondary: To measure the serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin in Vietnamese CKD population at 4th, 8th, 12th month., The serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin will be measured in mg/dL. The change of results during treatment will be described and will be compared in 3 different groups, at 4th, 8th and 12th month|To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population at 4th, 8th, 12th month., The level of Taurine, Tryp, and Kyn will be measured in micromol/L. The change of results during treatment will be described and will be compared in 3 different groups, at 4th, 8th and 12th month|To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population at 4th, 8th, 12th month., The number of red blood cell, white blood cell, and platelet will be measured in number/L. The change of results during treatment will be described and will be compared in 3 different groups, at 4th, 8th and 12th month|To measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month., The serum level of MDA will be serum in nmol/L. The change of results during treatment will be described and will be compared in 3 different groups, at 4th, 8th and 12th month|To measure the serum levels of SGOT, SGPT and Creatinine Kinase in Vietnamese CKD population at 4th month, 8th month and the 12th month, The unexpected effects of each treatment therapy on the liver and on the muscle will be accessed by measuring the level of SGOT, SGPT and Creatinine Kinase. These laboratory test will be measured at 4th month, 8th month and the 12th month. These results will be compared in 3 different groups, at 4th, 8th and 12th month|To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population at 4th, 8th, 12th month., The level of Albuminuria and urine Creatinine will be measured in mg/dL. The change of results during treatment will be described and will be compared in 3 different groups, at 4th, 8th and 12th month
Sponsor/Collaborators: Sponsor: Hue University of Medicine and Pharmacy | Collaborators: Università degli Studi di Sassari
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-06-15
Completion Date: 2020-10-15
Results First Posted:
Last Update Posted: 2019-08-13
Locations: Hue University of Medicine and Pharmacy, Hue, Thua Thien Hue, 0234, Vietnam
URL: https://clinicaltrials.gov/show/NCT03543774