Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01755104
Eligibility Criteria:
Inclusion Criteria:
* With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
* With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :
* Arterial Blood pressure \> or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
* Fasting glycemia \> or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic \< 1.26 g/L,
* Triglycerides \> or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
* HDL Cholesterol \<0.40 g/L or 1.03 mmol/L (males) and \<0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.
Exclusion Criteria:
* Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
* Woman of childbearing potential without an efficient contraception method,
The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01755104
Study Brief:
Protocol Section:
NCT01755104