A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program
Obesity
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Hypertension, Hyperlipidemia, Type 2 Diabetes, Life style modification
Eligibility Criteria
Inclusion Criteria: Body Mass Index (BMI) >= 33 and < 50 kg/m2 BMI >=30 and < 50 kg/m2 if patients have controlled hypertension or abnormal blood lipids Stable weight Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) Randomization criteria: Weight reduction of more than 8% of enrollment body weight during the eight week run-in phase Exclusion Criteria: Prior exposure, known contraindication, or hypersensitivity to topiramate Exposure to any other experimental drug or device within last 30 days A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed) History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels History of obesity with known cause History or family history of kidney stones History of weight loss surgery or liposuction History of malignancy within last 5 years History of an eating disorder