Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

NCT ID: NCT02213224

Last Updated: 2014-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Nonalcoholic Fatty Liver Disease (NAFLD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Perindopril

Perindopril 4mg qd taken in the morning;

Group Type EXPERIMENTAL

Perindopril

Intervention Type DRUG

Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Telmisartan

Telmisartan 80mg qd taken in the morning;

Group Type EXPERIMENTAL

Telmisartan

Intervention Type DRUG

Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Amlodipine

Amlodipine;5mg qd taken in the morning.

Group Type PLACEBO_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.

Interventions

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Perindopril

Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Intervention Type DRUG

Telmisartan

Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Intervention Type DRUG

Amlodipine

Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.

Intervention Type DRUG

Other Intervention Names

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Perindopril; brand name: Acertil, serial number:H20034053 Telmisartan; brand name: Micardis, serial number:J20090089 Amlodipine;5mg qd taken in the morning.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Side Liu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Side Liu, MD,PhD

Role: CONTACT

+86 020 61641537

Facility Contacts

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Yue Li, MD

Role: primary

+86-15975537291

Other Identifiers

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NAFLD20140805

Identifier Type: -

Identifier Source: org_study_id

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