| Trial ID: | L0623 |
| Source ID: | EUCTR2014-003638-26-SE
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
A double-blind randomized placebo-controlled, parallel-group 12 week study to investigate the effects of Epanova?? and dapagliFlozin on liver Fat contEnt in type 2 diabetiC patienTs; - EFFECT II
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Patients with type 2-diabetes who have Non-alcoholic fatty liver disease
(NAFLD);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
|
| Interventions: |
<br>Trade Name: Epanova<br>Product Name: Epanova<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: omega-3-carboxylic acid<br>Current Sponsor code: OMEFAS<br>Other descriptive name: OMEGA-3 FATTY ACIDS<br>Concentration unit: mg milligram(s)<br
|
| Outcome Measures: |
Main Objective: To evaluate the efficacy of the combination therapy (Epanova?? +<br>dapagliflozin) when compared to placebo with respect to reduction in<br>liver fat content (%) at the end of 12 weeks of double-blinded<br>treatment.;Secondary Objective: To evaluate the relative efficacy between Epanova?? + dapagliflozin,<br>Epanova??, dapagliflozin and placebo with respect to reduction in liver<br>fat at the end of 12 weeks of double-blind treatment.;Primary end point(s): Change from baseline to week 12 in the % liver fat content (??) as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatmentSecondary end point(s): Change from baseline to week 12 in the % 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: |
AstraZeneca AB
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| 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: no
Number of treatment arms in the trial: 4
|
| Start Date: |
03/10/2014
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
11 April 2016
|
| Locations: |
Sweden
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003638-26
|
