| Trial ID: | L0885 |
| Source ID: | EUCTR2014-003637-26-SE
|
| Associated Drug: |
Fenofibrate
|
| Title: |
A double-blind randomized placebo-controlled, parallel-group 12 week study to investigate the effects of Epanova?? compared to placebo and compared to Fenofibrate on liver Fat content in hypertriglyceridemic overwEight subjeCTs; EFFECT I - Effect I
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Patients with overweight and high serum triglyceride levels who have Non-alcoholic fatty liver disease;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
|
| Interventions: |
<br>Trade Name: Epanova<br>Product Name: Epanova<br>Product Code: C10AX06<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: omega-3-carboxylic acids<br>Current Sponsor code: OMEFAS<br>Other descriptive name: Omega-3 FATTY ACID<br>Concentration
|
| Outcome Measures: |
Main Objective: Tto evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) in overweight patients with no diabetes, at the end of 12 weeks of double blind treatment;Secondary Objective: To evaluate the efficacy of Epanova compared to fenofibrate with respect to reduction in liver fat content (%) in overweight patients with no diabetes, at the end of 12 weeks double blind treatment;Primary end point(s): The difference from baseline to week 12 in liver fat content (%), as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment Secondary end point(s): The difference from baseline to week 12 in liver fat content (%), as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment
|
| Sponsor/Collaborators: |
AstraZenenca AB
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
--
|
| 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: yes
Placebo: yes
Other: yes
Other specify the comparator: Fenofibrate
Num
|
| Start Date: |
23/01/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 May 2017
|
| Locations: |
Sweden
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003637-26
|
