| Trial ID: | L0698 |
| Source ID: | ACTRN12606000411549
|
| Associated Drug: |
AT1 receptor
|
| Title: |
A study of the safety and effects of AT1 (angiotensin type 1) receptor blockade with the angiotensin receptor II antagonist, telmisartan, on hepatic fibrogenesis in patients with non-alcoholic steatohepatitis (NASH).
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic steatohepatitis (NASH); <br>Non-alcoholic steatohepatitis (NASH);Inflammatory and Immune System - Liver
|
| Interventions: |
12 months of oral telmisartan therapy (20-80mg per day). Participants will begin at 20mg and this dose will be increased in 20mg increments until the maximum tolerated dose is reached up to 80mg per day.
|
| Outcome Measures: |
The primary objective of this study is to assess the effects of blockade of the angiotensin type 1 (AT1) receptor with the angiotensin receptor II antagonist, telmisartan, on hepatic fibrogenesis in patients with non-alcoholic steatohepatitis.[Measured at 12 months]Safety and tolerability of angiotensin type 1 (AT1) receptor antagonism in this patient group.[Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.];Effects of telmisartan on insulin resistance[Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.]
|
| Sponsor/Collaborators: |
Professor Peter Angus
|
| Gender: |
All
|
| Age: |
18 YearsNot stated
|
| Phases: |
Phase 2
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
|
| Start Date: |
20/09/2006
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
13 January 2020
|
| Locations: |
Australia
|
| URL: |
https://anzctr.org.au/ACTRN12606000411549.aspx
|
