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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01184560
Eligibility Criteria:
MAOInclusion Criteria:
1. A patient who gave one's voluntary written consent to participate in this clinical study
2. Aged ≥ 18 and \< 50 years old
3. An obese patient with a body mass index (BMI) ≥ 27 kg/m2
4. In case of a women, premenopausal woman
Exclusion Criteria:
1. A patient with the weight change ≥ 5% over the past 3 months
2. A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
3. A patient with an active acute or chronic disease at the participation of the study
4. A patient with the malignancy history within the past 5 years
5. A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
6. A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
7. A patient falling under the followings from screening test results Hemoglobin \< 10g/L or platelets \< 100\* 103/μL Total bilirubin \> 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) \> 120 IU/L Serum creatinine \> 1.4mg/dL Serum uric acid \> 10mg/dL Thyroid stimulating hormone \< 0.1μIU/mL or \> 6.5 μIU/mL
8. A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
9. A pregnant women or breastfeeding mother
10. A patient participating in another clinical study other than this study
11. Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
12. A person who participated in other clinical study within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01184560
Study Brief:
Protocol Section:
NCT01184560