A Pilot study to evaluate the Efficacy and Safety of GFT505 (80 mg) orally administered once daily for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.

GENFIT0 sites90 target enrollmentNovember 14, 2008

Overview

No summary available.

Registry

who.int

Start Date

November 14, 2008

End Date

September 24, 2009

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
•1\) Provide written informed consent prior to enrolment.
•2\) Male or post\-menopausal female (defined as \>12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy if any\- surgical removal of ovaries can be considered as surgical menopause”)).
•3\) Aged from 18 to 75 years.
•4\) Waist circumference \=102cm for male, \= 88cm for female.
•5\) Atherogenic dislipidaemia\* inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise). \* (documented or highly probable at V1\)
•6\) Patients without previous experience of CVD\*\*.
•\*\* Cardiovascular disease will be defined as:
•1\) Peripheral Artery Disease
•a) Lower limb \[history of acute leg ischemia or clinical symptoms of arteriopathy (intermittent claudication)]

•1\) Body Mass Index (BMI) \= 40 kg/m².
•2\) Weight change (variation \>5%) within 6 months at least prior to screening.
•3\) Known Heart Failure (Grade I to IV of NYHA classification).
•4\) Blood Pressure \> 160 / 95 mmHg.
•5\) Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.
•6\) Type I or type II Diabetes Mellitus.
•7\) Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease.
•8\) Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
•9\) Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non\-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
•10\) Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study