MULTICENTRIC PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ECOPIPAM IN THE MANAGEMENT OF OBESITY

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2000年2月15日最近更新: 2023年9月4日

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•The subjects must be 18 years of age or older, of any gender and of any race.
•The subjects must have a BMl between 30 and 45, inclusive, measured at Scrutiny (Week -4).
•Subjects must be able to understand and be willing to give their informed consent and be able to adhere to the requirements of the study.
•Women should not be lactating and should not be able to get pregnant (ie, sterilized via hysterectomy or because they have tied their tubes or at least be menopausal since a year before) or if they are of childbearing age, agree to practice a barrier method of contraception effective, use an intrauterine abutment (lUD) or use contraceptive pills or an equivalent injectable contraceptive.

•Subjects who have participated in a clinical study and who have received a research drug in the 30 days prior to the Scrutiny.
•Subjects with a severe or unstable medical condition (e.g., recent surgery, stroke, myocardial infarction or neoplasia). Subjects with Parkinson´s disease, epilepsy, known EEG abnormalities, renal disease, neutropenia (neutrophils less than 1500 mm) and hepatic disease (e.g., viral or alcohol-induced hepatitis) will be excluded.
•Subjects with a severe or unstable psychiatric condition (e.g., schizophrenia, dementia or bipolar disorder) will be excluded.
•Subjects with diabetes or hypertension that require drug therapy.
•Subjects whose obesity is due to an identifiable metabolic or endocrinological syndrome such as the Cushing, Prader-Willi or Laurence-Moon-Bieldl syndromes.
•Clinical laboratory tests (e.g., blood chemistry, general urine) that are outside of normal limits that are clinically unacceptable to the Investigator or the Sponsor.
•Women who are pregnant or nursing.
•Subjects who have known hypersensitivity to ecopipam or any of its excipients.
•Subjects who have taken prohibited medications during the 60 days prior to the scrutiny
•Subjects with a known history of dependence on drugs or alcohol.

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