| Trial ID: | L0697 |
| Source ID: | EUCTR2007-003013-14-PT
|
| Associated Drug: |
Rimonabant
|
| Title: |
A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of Type 2 diabetic patients with nonalcoholic steatohepatitis (NASH) - STRONG2
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Diabetic patients with Non-Alcoholic Steato-Hepatitis <br>MedDRA version: 9.1
Level: LLT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
;Diabetic patients with Non-Alcoholic Steato-Hepatitis <br>MedDRA version: 9.1
Level: LLT
Classificat
|
| Interventions: |
<br>Trade Name: ACOMPLIA<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: rimonabant<br>CAS Number: 168273-06-01<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 20-<br>Pharmaceutical form of t
|
| Outcome Measures: |
Main Objective: The primary objective of this study is to demonstrate in patients with co-morbid Type 2 diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo for improving the severity of NASH as measured by histological features of liver injury.;Secondary Objective: The secondary objectives of this study are to demonstrate in patients with co-morbid diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo: <br>1) In severity of hepatic fibrosis as measured by hepatic fibrosis stage; <br>2) In level of circulating plasma adiponectin; <br>3) In level of circulating hyaluronate; <br>4) In degree of insulin sensitivity; <br>and, <br>5) In AST/ALT level.<br>;Primary end point(s): The primary efficacy endpoint is the mean change per year in NAS (NAFLD Activity score) between baseline and end of study biopsy evaluation. ;Main Objective: The primary objective of this study is to demonstrate in patients with co-morbid Type 2 diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo for improving the severity of NASH as measured by histological features of liver injury.;Secondary Objective: The secondary objectives of this study are to demonstrate in patients with co-morbid diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo: <br>1) In severity of hepatic fibrosis as measured by hepatic fibrosis stage; <br>2) In level of circulating plasma adiponectin; <br>3) In level of circulating hyaluronate; <br>4) In degree of insulin sensitivity; <br>and, <br>5) In AST/ALT level.<br>;Primary end point(s): The primary efficacy endpoint is the mean change per year in NAS (NAFLD Activity score) between baseline and end of study biopsy evaluation. nan
|
| Sponsor/Collaborators: |
sanofi-aventis recherche & development
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
720
|
| 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: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
| Start Date: |
17/08/2007
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
11 September 2012
|
| Locations: |
Hungary;Portugal;United Kingdom;Germany;Belgium;France;Spain;Italy;Hungary;Portugal;United Kingdom;Germany;Belgium;France;Spain;Italy
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003013-14
|
