Nonalcoholic Fatty Liver Disease (NAFLD)Phase 4NF-NAFLDNCT02213224
Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease
A Phase 4 study testing Perindopril, Telmisartan and Amlodipine in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Perindopril, Telmisartan and Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Yue Li, MD, +86-15975537291, liyue_1989919@126.com
Side Liu, MD.PhD
About this study
Official title: Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Being tested
- Perindopril, Telmisartan, Amlodipine
- Keywords
- Perindopril,Telmisartan, Efficacy, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
Also called Perindopril; brand name: Acertil, serial number:H20034053
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.
TelmisartanDrug
Also called Telmisartan; brand name: Micardis, serial number:J20090089
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.
AmlodipineDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Perindopril | Experimental | Perindopril 4mg qd taken in the morning; Receives: Drug: Perindopril |
| Telmisartan | Experimental | Telmisartan 80mg qd taken in the morning; Receives: Drug: Telmisartan |
| Amlodipine | Placebo comparator | Amlodipine；5mg qd taken in the morning. Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks after the treatment
Secondary outcomes (6)
Angiotensin II
Measured: 12, 24, 48 weeks after the treatment
IL-18，IL-1β
Measured: 12, 24, 48 weeks after the treatment
aminotransferase
Measured: 12, 24, 48 weeks after the treatment
lipids
Measured: 12, 24, 48 weeks after the treatment
HOMA-IR
homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 12, 24, 48 weeks after the treatment
computed tomography value of liver
Measured: 48 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Side Liu, MD,PhD, Principal investigator, Department of Gastroenterology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213224
- Sponsor's protocol ID
- NAFLD20140805
- Acronym
- NF-NAFLD
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02213224
- Acronym / sponsor ID
- NF-NAFLD / NAFLD20140805
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Keywords
- Perindopril,Telmisartan, Efficacy, NAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perindopril | Experimental | Drug: PerindoprilPerindopril 4mg qd taken in the morning; |
| Telmisartan | Experimental | Drug: TelmisartanTelmisartan 80mg qd taken in the morning; |
| Amlodipine | Placebo comparator | Drug: AmlodipineAmlodipine；5mg qd taken in the morning. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerindoprilAlso: Perindopril; brand name: Acertil, serial number:H20034053Perindopril 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. | Drug | Perindopril |
| TelmisartanAlso: Telmisartan; brand name: Micardis, serial number:J20090089Telmisartan 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. | Drug | Telmisartan |
| AmlodipineAlso: 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. | Drug | Amlodipine |
Primary outcome
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.
6 secondary outcomes
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
computed tomography value of liver
Time frame: 48 weeks after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Side Liu, MD,PhD principal investigator
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perindopril, Telmisartan and Amlodipine in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Side Liu, MD,PhD (+86 020 61641537, liuside2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cap value of FibroScan （dB/m） (time frame: 48 weeks after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.