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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT00386061
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI \>27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
* stable body weight (variation \<5 kg within 3 months prior to screening visit);
Exclusion Criteria:
* History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
* Presence of any clinically significant psychiatric , neurological or endocrine disease
* Presence of treated or untreated type 1 or type 2 diabetes);
* SBP \>165 mmHg and/or DBP \>105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
* History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
* Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;
The investigator will evaluate whether there are other reasons why a patient may not participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00386061
Study Brief:
Protocol Section:
NCT00386061