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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze.

• Study phase: Investigator-initiated clinical study (Pilot study)

• Method of blinding: Double-blind

• Control: Placebo-controlled

• Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1)

• Studied disease: Obesity

• Study population: Subjects eligible for inclusion/exclusion criteria

• Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Treatments: Orlistat; Sibutramine

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