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Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity

NCT01271751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2011-01-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.

Conditions

  • Atherogenic Dyslipidaemia
  • Abdominal Obesity

Interventions

DRUG

GFT505 80mg

hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

DRUG

Placebo

hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Rémy Hanf, Development Director · GENFIT, France

  • Eric BRUCKERT, Pr. · University Hospital of Paris 6, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-09-30
Completion
2009-11-30

Countries

  • France
  • Romania
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271751 on ClinicalTrials.gov