Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-08 @ 9:12 PM
Study NCT ID:
NCT01703260
Status:
TERMINATED
Last Update Posted:
2017-02-01
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
Sponsor:
AstraZeneca
Organization:
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision; No safety or efficacy concerns (see detailed description)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.
Detailed Description:
This proof of concept study will evaluate the effect of roflumilast and pioglitazone on transaminase levels and liver fat content.
Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol.
The decision to terminate the study is not related to any safety concerns with either of the study medications.
Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol.
The decision to terminate the study is not related to any safety concerns with either of the study medications.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1129-5051 | REGISTRY | WHO | View |