Status:
COMPLETED
Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Lead Sponsor:
Gachon University Gil Medical Center
Conditions:
Obesity
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- MAO
- A patient who gave one's voluntary written consent to participate in this clinical study
- Aged ≥ 18 and \< 50 years old
- An obese patient with a body mass index (BMI) ≥ 27 kg/m2
- In case of a women, premenopausal woman
Exclusion
- A patient with the weight change ≥ 5% over the past 3 months
- A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
- A patient with an active acute or chronic disease at the participation of the study
- A patient with the malignancy history within the past 5 years
- A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
- 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
- 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
- A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
- A pregnant women or breastfeeding mother
- A patient participating in another clinical study other than this study
- Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
- A person who participated in other clinical study within the past 3 months
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01184560
Start Date
February 1 2010
End Date
July 1 2010
Last Update
August 19 2010
Active Locations (1)
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1
GachonGill Medical Center
Inchon, Namdong-gu, South Korea