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Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

NCT03543774 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-13

No results posted yet for this study

Summary

This study aims to determine the mechanisms underlying dyslipidemia in chronic kidney disease (CKD) and effect of lipid-lowering therapies in patients with CKD via parameters of lipid, oxidative stress, tryptophan delegation as well as renal function and side effects. Thirty 3,4 CKD patients with low-density lipoprotein (LDL) \> 100 mg/mL (2,59mmol/l), randomly receive three different LDL lipid-lowering therapies: Simvastatin (40 mg/day) or ezetimibe/simvastatin combination (10/20 mg/day or 10/40 mg/day).

Conditions

Interventions

DRUG

Simvastatin 40mg

Simvastatin mono-therapy at the dose of 40 mg/day for 12 months

DRUG

Ezetimibe/simvastatin 10/20 mg/day

Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months

DRUG

Ezetimibe/simvastatin 10/40 mg/day

Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months

Sponsors & Collaborators

  • Università degli Studi di Sassari

    collaborator OTHER

  • Hue University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Duong Thi Ngoc Lan, Master · Hue University of Medicine and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-03-15
Completion
2020-10-15
FDA Drug
Yes

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543774 on ClinicalTrials.gov