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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01773733
Eligibility Criteria:
Inclusion Criteria:
* Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated.
* Patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance.
* Signed informed consent form for participation in the program.
Exclusion Criteria:
\- Patients under age of 18 or older than 65;
Current or the history of:
* coronary artery disease (e.g. angina, myocardial infraction);
* congestive heart failure;
* tachycardia;
* peripheral arterial occlusive disease;
* arrythmia;
* Uncontrolled arterial hypertension \>145/90 mm Hg;
* Hypersensitivity to sibutramine or any components of Reduxine®;
* Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks;
* Current use of other central acting weight reducing drugs or their use within the last 2 weeks;
* Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance;
* Severe eating disorder (anorexia nervosa or bulimia);
* Mental disease;
* Gilles de la Tourette syndrome (generalized tics);
* Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes);
* Organic cause of obesity (e.g. hypothyrosis);
* Thyrotoxicosis;
* Sever liver and/or kidney function abnormality;
* Benign prostatic hyperplasia;
* Phaeochromocytoma;
* Narrowangle glaucoma;
* Documented pharmacologic, drug or alcohol addiction;
* Pregnancy and lactation;
* Refusal to sign the informed consent form for participation in the program;
* Participation in a clinical study of any new drug product within 90 days prior to the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01773733
Study Brief:
Protocol Section:
NCT01773733