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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02354976 |
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Date of registration:
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30/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
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Scientific title:
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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 |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02354976 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Lars Lind, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University Hospital. Uppsala Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria: - Provision of informed consent
- Men or women =40 years and =75 years with suitable veins for cannulation or repeated
venepuncture
- Have serum triglycerides =1.7 mM
- Have liver fat content as assessed by MRI >5.5%
- Have a body mass index (BMI) >25 and =40 kg/m2
, Exclusion Criteria: - History of or presence of any clinically significant disease
or disorder which, in the opinion of the investigator, may either put the subject at
risk because of participation in the study, or influence the results or the subject's
ability to participate in the study.
- Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).
- Severe hepatic insufficiency and/or significant abnormal liver function defined as
aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine
aminotransferase (ALT) >3x ULN
- Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose >7.0 mM or use
of antidiabetic therapy
- Any clinically significant abnormalities in clinical chemistry, haematology or
urinalysis results as judged by the investigator. This includes signs of liver disease
other than NAFLD that motivates further investigations of treatment based on clinical
judgement
- Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to
be defined as >14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard
liquor) or as judged by the investigator
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertriglyceridemia
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Non-alcoholic Fatty Liver Disease (NAFLD
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Intervention(s)
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Drug: Omega-3 carboxylic acid
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Drug: Fenofibrate 200mg
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Drug: Placebo
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Primary Outcome(s)
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Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
[Time Frame: 12 weeks]
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Secondary ID(s)
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D5881C00007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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