PER-065-07已完成未知
A PHASE IIA, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF MK-0773 IN PATIENTS WITH SARCOPENIA
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2007年9月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •The patient is a woman> 65 years old on the day of signing the informed consent.
- •The patient has an aLBM / Ht2, measured by the DEXA,> 1 SD below the average of a healthy young adult population (maximum).
- •The patient has self-reported difficulty climbing 10 steps or walking 1/4 mile off flat terrain without resting.
- •The patient has a SPPB score of 4-9.
- •The patient is mentally competent - she has obtained a score> 21 on the Folstein State Examination (MMSE) in the selection (Visit 1) and, in the opinion of the Researcher, is able to understand and follow the study procedures.
- •The patient is considered to have a satisfactory state of health according to her medical history, physical examination, ECG and the laboratory evaluations of the selection.
- •The patient has an adequate organic function as indicated by the following laboratory values (Table 2-1) in the selection (Visit 1):
- •All of the patient´s liver function tests are within the normal range.
排除标准
- •The patient has neuromuscular diseases (Parkinson´s disease, amyotrophic lateral sclerosis, stroke that affect the function of the lower extremities and muscular dystrophy).
- •The patient has rheumatoid arthritis.
- •The patient has diseases that cause muscle pain or significant arthralgia or significantly limited mobility including polymyalgia rheumatica, polymyositis and fibromyalgia. Note: Patients suffering from diseases such as osteoarthritis can participate unless the pain limits them in the execution of the study procedures. Patients with polymyalgia that affects only limited parts of the upper body (ie, neck, shoulder) can participate in the study.
- •The patient has chronic lung disease that limits their mobility as a result of respiratory function.
- •The patient has any other disease that, according to the opinion of the researcher or the SPONSOR, can have an impact on the evaluation of the improvement of muscle strength and function.
- •The patient suffers from epilepsy, multiple sclerosis or focalized lesions.
- •The patient presents psychiatric disorders of axis I in the 6 months prior to selection (Visit 1) as determined by the Diagnostic and Statistical Manual of Mental Disorders, in its Fourth Edition (DSM-IV).
- •The patient has depression inadequately treated as assessed by a score> 10 of the Patient Health Questionnaire (PHQ-9) (Appendices 6.2 and 6.3). Note: Patients should receive stable doses of antidepressants for> 60 days to be eligible to participate.
- •The patient has mental or legal disability or significant emotional problems at the beginning of the study.
- •The patient has some other neurological or psychiatric disease that may affect her ability to provide informed consent and / or may impact on cognitive function.
- •The patient suffers from unstable angina, congestive heart failure of Class III or IV established by the New York Heart Association (New York Heart Association) (NYHA) or myocardial infarction within 6 months prior to the screening visit ( Visit 1).
- •The patient has uncontrolled hypertension (ie, systolic blood pressure in the sitting position> 160 mmHg and / or diastolic blood pressure in the sitting position> 100 mm Hg).
- •The patient has clinically significant orthostatic hypotension (ie, a decrease of 10 mm Hg in systolic blood pressure or an increase of 20 beats per minute after 5 minutes of standing).
- •Patient has (a) a history of marked baseline prolongation of the QT / QTc interval (eg: repeated demonstration of a QTc interval> 450) or (b) additional risk factors for Torsades de Pointes (eg: heart failure) , hypokalemia, family history of Prolonged QT Syndrome) or (c) concomitant use of drugs that prolong the QT / QTc interval (for example: quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone or sotalol),
- •The patient has symptomatic peripheral arteriovascular disease that, in the opinion of the researcher, probably affects the mobility and capacity of the patients to perform the study procedures.
- •The patient has significant cardiovascular disease.
- •The patient has a history of some type of cancer, with the following exceptions: a. Superficial basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, treated appropriately. b. Solid tumor treated definitively without a history of recurrence for at least 5 years before selection (Visit 1).
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