Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

NCT02213224 | Unknown Phase 4 DMC

• 1 other identifier: NAFLD20140805
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Keywords

Perindopril,Telmisartan, Efficacy, NAFLD

Outcome Measures

Primary Outcomes (1)

• Cap value of FibroScan （dB/m）

  FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.

  48 weeks after the treatment

Secondary Outcomes (6)

• Angiotensin II

  12, 24, 48 weeks after the treatment

• IL-18，IL-1β

  12, 24, 48 weeks after the treatment

• aminotransferase

  12, 24, 48 weeks after the treatment

• lipids

  12, 24, 48 weeks after the treatment

• HOMA-IR

  12, 24, 48 weeks after the treatment

Study Arms (3)

Perindopril

EXPERIMENTAL

Perindopril 4mg qd taken in the morning;

Drug: Perindopril

Telmisartan

EXPERIMENTAL

Telmisartan 80mg qd taken in the morning;

Drug: Telmisartan

Amlodipine

PLACEBO COMPARATOR

Amlodipine；5mg qd taken in the morning.

Drug: Amlodipine

Interventions

Perindopril 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.

Also known as: Perindopril; brand name: Acertil, serial number:H20034053

Perindopril

Telmisartan 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.

Also known as: Telmisartan; brand name: Micardis, serial number:J20090089

Telmisartan

Amlodipine 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.

Also known as: Amlodipine；5mg qd taken in the morning.

Amlodipine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old patients who were diagnosed with mild-moderate hypertension and NAFLD;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Perindopril; Telmisartan; Amlodipine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Side Liu, MD,PhD

  Department of Gastroenterology, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Side Liu, MD,PhD

CONTACT

+86 020 61641537; liuside2011@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

CN (1)