Full title of the trial A Study to Assess the Efficacy and Tolerability of MK-0364 in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension - A Weight Maintenance Study of MK-0364 PN012 with 1-year Extension

Merck Sharp & Dohme (Sweden) AB0 个研究点目标入组 600 人开始时间: 2006年9月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Patient has a body mass index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive and has maintained a stable weight (±3 kg) for at least 3 months prior to study start.
•2. Patient is male or female and between the ages of 18 and 65, inclusive, on day of signing informed consent.
•3. Patient loses at least 6% of initial body weight during the LCD period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder).
•2. Patient has a history of seizures or is at high risk of having seizures.
•3. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list.

发起方

Merck Sharp & Dohme (Sweden) AB