A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

Eli Lilly and Company0 个研究点目标入组 172 人开始时间: 2012年5月25日最近更新: 2014年6月30日

适应症

试验速览

暂无简介。

•- Males or females aged 75 years or older.
•- Sustained at least 1 fall within 1 calendar year prior to the screening visit.
•- Requires greater than or equals to12 seconds to perform a repeated chair stands test or is unable to complete this test at the screening visit.
•- Hand grip strength is less than or equal to 37 kg for men or less than or equal to 21 kg for women at the screening visit.
•- Can stand up from a chair and walk greater than or equal to10 meters without human assistance at the screening visit.
•- Able to climb at least 1 step on a staircase without human assistance according to the patient at the screening visit.
•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 172

•- Have a major active vestibular vertigo or a major neurologic disorder severely reducing their mobility.
•- Are unable to safely perform the protocol-specified tests of physical performance due to a major visual impairment.
•- Severe vitamin D deficiency before the randomization visit.
•- Current use or previous use of any drugs known to influence muscle mass or performance.
•- Have had a recent neurologic injury.
•- Have a history or presence of unstable cardiovascular comorbidities.
•- Have a positive fecal occult blood (FOB) test at screening or the patient cannot provide a stool sample for FOB testing prior to randomization.

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