| Trial ID: | L0695 |
| Source ID: | EUCTR2007-005089-12-FR
|
| Associated Drug: |
TRO19622
|
| Title: |
Study title: Double-blind vs Placebo, Randomized, Exploratory Study to
Assess the Short Term Effect on Liver Enzymes and the Safety of
TRO19622 500 mg QD for One Month in Patients with Non-Alcoholic
Steatohepatitis (NASH).
|
| Acronym: |
--
|
| Status: |
Authorised
|
| 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 Code: TRO 19622<br>Pharmaceutical Form: Capsule*<br>CAS Number: 22033-87-0<br>Current Sponsor code: TRO19622<br>Other descriptive name: 4-Cholesten-3-one, oxime<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentrati
|
| Outcome Measures: |
Main Objective: Exploratory study <br>Short term effect on liver enzymes of TRO19622 in patients with Non Alcoholic Steatohepatitis(NASH).;Secondary Objective: Safety;Primary end point(s): Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gendre, subject and time and a non parametric test (Conver-Salsburg)nan
|
| Sponsor/Collaborators: |
TROPHOS
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
| Start Date: |
04/10/2007
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 March 2012
|
| Locations: |
France
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005089-12
|
