A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients with Sarcopenia

aboratoires Merck Sharp & Dohme- Chibret0 个研究点目标入组 200 人开始时间: 2007年7月23日最近更新: 2019年6月30日

试验速览

暂无简介。

•1. Patient is a woman 65 years of age on day of signing the informed consent.
•2. Patient has an aLBM/Ht2, measured by DEXA, > 1 SD below the mean of a healthy
•young adult population (peak).
•3. Patient has self-reported difficulty in climbing 10 steps or walking ¼ mile outside on level ground without resting.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patient has performed any vigorous exercise (see below) in the 3 months prior to screening (Visit 1) or plans to substantially change the level of physical activity during the study.
•2. Patient has untreated depression, psychiatric conditions, respiratory illness, cardiac abnormalities and/or neuromuscular diseases (Parkinson’s disease, amyotrophic lateral sclerosis, stroke affecting lower extremity function and muscular dystrophy). Patient has conditions that cause significant muscular or joint pain or significantly limit mobility including rheumatoid arthritis, polymyalgia rheumatica, polymyositis, and fibromyalgia. Note: Patients with conditions such as osteoarthritis can participate unless their pain limits them from performing study procedures. Patients with polymyalgia affecting only limited parts of the upper body (i.e., neck, shoulder) can participate in the study.
•3. Patient has a history of any form of cancer, with the following exceptions:
•a. Adequately treated superficial basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
•b. Solid tumor definitively treated without any history of recurrence for at least 5 years prior to screening

发起方

aboratoires Merck Sharp & Dohme- Chibret