| Trial ID: | L0929 |
| Source ID: | NCT01703260
|
| Associated Drug: |
Roflumilast
|
| Title: |
A Randomized, Double-Blind, Controlled, Multi-Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver Enzymes and Liver Fat Content in Subjects With Nonalcoholic SteatoHepatitis
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT01703260
|
| Conditions: |
Nonalcoholic Steatohapatitis;Nonalcoholic Steatohapatitis;Nonalcoholic Steatohapatitis;Nonalcoholic Steatohapatitis
|
| Interventions: |
Drug: Roflumilast;Drug: Pioglitazone;Drug: Placebo;Drug: Placebo;Drug: Roflumilast;Drug: Pioglitazone;Drug: Placebo;Drug: Placebo;Drug: Roflumilast;Drug: Pioglitazone;Drug: Placebo;Drug: Placebo;Drug: Roflumilast;Drug: Pioglitazone;Drug: Placebo;Drug: Pla
|
| Outcome Measures: |
Amount of Serum Alanine Transaminase (ALT) at Baseline;Percent Change From Baseline in Serum ALT at Month 4;Amount of Serum Alanine Transaminase (ALT) at Baseline;Percent Change From Baseline in Serum ALT at Month 4Amount of Serum Aspartate Transaminase (AST) at Baseline;Percent Change From Baseline in Serum AST at Month 4;Liver Fat Content at Baseline;Change From Baseline in Liver Fat Content at Month 4
|
| Sponsor/Collaborators: |
AstraZeneca
|
| Gender: |
All
|
| Age: |
18 Years80 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
20
|
| Study Type: |
Interventional
|
| Study Designs: |
--
|
| Start Date: |
02/10/2012
|
| Completion Date: |
--
|
| Results First Posted: |
23/02/2016
|
| Last Update Posted: |
19 October 2017
|
| Locations: |
United States;United States;United States;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01703260
|
