Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Phase 4

• Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
• Interventions: Drug: Perindopril; Drug: Telmisartan; Drug: Amlodipine

• Registration Number: NCT02213224
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The aim of this current study was to assess the therapeutic effects of perindopril and telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic effects of these two kind of drugs.

This study is a randomized parallel control clinical trial which would be carried out in Nanfang Hospital, Southern Medical University.

About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan and amlodipine three groups.

Detailed Description

Inclusion criteria:

18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.

Exclusion criteria:

There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-08
• Last Update Submitted: 2014-08-08
• Study First Posted: 2014-08-11
• Last Update Posted: 2014-08-11
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD;
• The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.

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Exclusion Criteria

• There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases;
• Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly;
• Pregnancy and nursing mothers;
• Allergic constitution or intolerance to ACEIs or ARBs drugs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perindopril	Perindopril	Perindopril 4mg qd taken in the morning;
Telmisartan	Telmisartan	Telmisartan 80mg qd taken in the morning;
Amlodipine	Amlodipine	Amlodipine；5mg qd taken in the morning.

Primary Outcome Measures

Name	Time	Method
Cap value of FibroScan （dB/m）	48 weeks after the treatment	FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.

Secondary Outcome Measures

Name	Time	Method
computed tomography value of liver	48 weeks after the treatment
lipids	12, 24, 48 weeks after the treatment
Angiotensin II	12, 24, 48 weeks after the treatment
aminotransferase	12, 24, 48 weeks after the treatment
IL-18，IL-1β	12, 24, 48 weeks after the treatment
HOMA-IR	12, 24, 48 weeks after the treatment	homeostasis model assessment of insulin resistance (HOMA-IR)

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 GuangZhou, Guangdong, China