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A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia

Intervention: Placebo (Drug); Omega-3 carboxylic acid (Drug); Fenofibrate 200mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Lars Lind, Professor, Principal Investigator, Affiliation: Uppsala University Hospital. Uppsala Sweden

Overall contact:
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

Summary

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Difference from baseline to week 12 in the % liver fat content as measured by MRI.

Secondary outcome: Difference from baseline to week 12 in the % liver fat content as measured by MRI.

Eligibility

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

Research Site, Göteborg, Sweden; Not yet recruiting

Research Site, Malmö, Sweden; Not yet recruiting

Research Site, Uppsala, Sweden; Not yet recruiting

Additional Information

Starting date: August 2015
Last updated: July 29, 2015

Page last updated: August 23, 2015

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