Trials / Completed
CompletedNCT00668070
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
Protocol for 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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period
Detailed description
The study includes an open-label sub-study prior to the main study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASP9831 | Oral |
| DRUG | Placebo | Oral |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2008-04-28
- Last updated
- 2013-03-21
Locations
30 sites across 7 countries: Belgium, Czechia, France, Germany, Romania, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00668070. Inclusion in this directory is not an endorsement.