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
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|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Perindopril 4mg qd taken in the morning;
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
Telmisartan 80mg qd taken in the morning;
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.
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.
- 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.
- Angiotensin II [ Time Frame: 12, 24, 48 weeks after the treatment ]
- IL-18，IL-1β [ Time Frame: 12, 24, 48 weeks after the treatment ]
- aminotransferase [ Time Frame: 12, 24, 48 weeks after the treatment ]
- lipids [ Time Frame: 12, 24, 48 weeks after the treatment ]
- HOMA-IR [ Time Frame: 12, 24, 48 weeks after the treatment ]homeostasis model assessment of insulin resistance (HOMA-IR)
- computed tomography value of liver [ Time Frame: 48 weeks after the treatment ]
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
|Contact: Side Liu, MD,PhD||+86 020 firstname.lastname@example.org|
|Nanfang Hospital, Southern Medical University||Recruiting|
|GuangZhou, Guangdong, China, 510515|
|Contact: Yue Li, MD +86-15975537291 email@example.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|
|Principal Investigator:||Side Liu, MD,PhD||Department of Gastroenterology, Nanfang Hospital, Southern Medical University|