EUCTR2007-002383-95-IT进行中（未招募）不适用
A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy andSafety of MK-0773 in Patients with Sarcopenia. - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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).
- •Patient has self-reported difficulty in climbing 10 steps or walking Œ mile outside on
- •level ground without resting.
- •4) Patient has an SPPB score that is 4-9.
- •5) Patient is mentally competent - has scored ≥21 on the Folstein?s Estate Examination
- •(MMSE) at screening (Visit 1) and in the opinion of the Investigator is able to
- •understand and follow study procedures.
- •6) Patient is judged to be in satisfactory health based on medical history, physical
- •examination, ECG, and laboratory screening evaluations.
- •7) Patient has adequate organ function as indicated by the following laboratory valuesat screening (Visit 1)
- •8) Patient liver function tests are all within the normal range.
- •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
排除标准
- •Patient has neuromuscular diseases (Parkinson?s disease, amyotrophic lateral
- •sclerosis, stroke affecting lower extremity function and muscular dystrophy).
- •2) Patient has rheumatoid arthritis.
- •3) Patient has conditions that cause significant muscular or joint pain or significantly
- •limit mobility including 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
- •4) Patient has chronic lung disease that limits mobility as a result of respiratory
- •5) Patient has any other condition which, in the opinion of the investigator or
- •SPONSOR, may impact the assessment of improved muscle strength and function.
- •6) Patient has epilepsy, multiple sclerosis, or focal lesions.
- •7) Patient has axis I psychiatric disorders in the 6 months prior to screening (Visit 1) as
- •determined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth
- •Edition (DSM-IV).
- •8) Patient has inadequately treated depression as assessed by a Patient Health
- •Questionnaire (PHQ-9) score of ≥10 (Appendices 6.2 and 6.3). Note: Patients must
- •be on stable doses of antidepressants for >60 days to be eligible to participate.
- •9) Patient has mental or legal incapacitation, or significant emotional problems at the
- •start of the study.
- •10) Patient has any other neurological or psychiatric condition that may affect the
- •patient?s ability to provide informed consent and/or can impact cognitive function.
- •11) Patient has unstable angina or New York Heart Association (NYHA) Class III or IV
- •congestive heart failure.
研究者
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