Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Launched by GACHON UNIVERSITY GIL MEDICAL CENTER · Aug 18, 2010

Keywords

ClinConnect Summary

After the screening period, patients eligible for inclusion/exclusion criteria would administer Sibutramine placebo and Orlistat placebo during 2 weeks of the run-in period, Subsequently, subjects are randomized to 2 groups of the Sibutramine monotherapy group and the Orlistat and Sibutramine combination group. Sibutramine monotherapy group would receive Sibutramine 10mg once daily and Orlistat placebo three times daily for 12 weeks; the Orlistat and Sibutramine combination group would receive Sibutramine 10mg once daily and Orlistat 120mg three times daily for 12 weeks. After completing th...

Gender

ALL

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