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Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease (NF-NAFLD)

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ClinicalTrials.gov Identifier: NCT02213224
Recruitment Status : Unknown
Verified August 2014 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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.


Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease (NAFLD) Drug: Perindopril Drug: Telmisartan Drug: Amlodipine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
Study Start Date : August 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: Perindopril
Perindopril 4mg qd taken in the morning;
Drug: 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.
Other Name: Perindopril; brand name: Acertil, serial number:H20034053

Experimental: Telmisartan
Telmisartan 80mg qd taken in the morning;
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.
Other Name: Telmisartan; brand name: Micardis, serial number:J20090089

Placebo Comparator: Amlodipine
Amlodipine;5mg qd taken in the morning.
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.
Other Name: Amlodipine;5mg qd taken in the morning.




Primary Outcome Measures :
  1. Cap value of FibroScan (dB/m) [ Time Frame: 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 :
  1. Angiotensin II [ Time Frame: 12, 24, 48 weeks after the treatment ]
  2. IL-18,IL-1β [ Time Frame: 12, 24, 48 weeks after the treatment ]
  3. aminotransferase [ Time Frame: 12, 24, 48 weeks after the treatment ]
  4. lipids [ Time Frame: 12, 24, 48 weeks after the treatment ]
  5. HOMA-IR [ Time Frame: 12, 24, 48 weeks after the treatment ]
    homeostasis model assessment of insulin resistance (HOMA-IR)

  6. computed tomography value of liver [ Time Frame: 48 weeks after the treatment ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213224


Contacts
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Contact: Side Liu, MD,PhD +86 020 61641537 liuside2011@163.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
GuangZhou, Guangdong, China, 510515
Contact: Yue Li, MD    +86-15975537291    liyue_1989919@126.com   
Principal Investigator: Side Liu, MD.PhD         
Sub-Investigator: Yue Li, MD         
Sub-Investigator: Xu Li, MD         
Sub-Investigator: Zelong Han, MD         
Sub-Investigator: Wen Xu, MM         
Sub-Investigator: Yubin Guo, MM         
Sub-Investigator: Feng Xiong, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Side Liu, MD,PhD Department of Gastroenterology, Nanfang Hospital, Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02213224     History of Changes
Other Study ID Numbers: NAFLD20140805
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014
Keywords provided by Nanfang Hospital of Southern Medical University:
Perindopril,Telmisartan, Efficacy, NAFLD
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Amlodipine
Telmisartan
Perindopril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors