| Trial ID: | L0694 |
| Source ID: | EUCTR2007-002114-19-DE
|
| Associated Drug: |
ASP9831
|
| Title: |
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTER
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis (NASH) <br>MedDRA version: 9.1
Level: LLT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
|
| Interventions: |
<br>Product Name: ASP9831<br>Product Code: ASP9831<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: ASP9831<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the pl
|
| Outcome Measures: |
Primary end point(s): Percentage change in serum ALT at the end of treatment at 12 weeks compared to baseline;Main Objective: Part 1: Objective:<br>To explore exposure to ASP9831 in patients with Non-alcoholic Steatohepatitis (NASH) and to compare the data with healthy volunteer data<br><br>Part 2: Primary objective:<br>To study the effect of a 12 week treatment with two dose levels of ASP9831 compared to placebo on liver injury by assessing serum levels of Alanine Aminotransferase (ALT) in subjects with NASH;Secondary Objective: Part 2: Secondary objectives:<br>?€? To study the safety of two dose levels of ASP9831 compared to placebo in subjects with NASH<br>?€? To perform an exploratory analysis of<br>o the effect of ASP9831 on hepatic steatosis<br>o the effect of ASP9831 on liver inflammation and vascular damage<br>o the effect of ASP9831 on other liver injury markers<br>o the effect of ASP9831 on liver fibrosis<br>o the effect of ASP9831 on insulin resistance<br>o the effect of ASP9831 on clinical symptoms<br>o the pharmacokinetics and the pharmacokinetic / pharmacodynamic relationships of ASP9831 in the study populationnan
|
| Sponsor/Collaborators: |
Astellas Pharma Europe B.V.
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
105
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Part 1: open-label
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other
|
| Start Date: |
30/11/2007
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 January 2013
|
| Locations: |
France;Czech Republic;Belgium;Germany;United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002114-19
|
