A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Sarcopenia

Treatments: Drug: Comparator: Placebo; Drug: Comparator: MK-0773

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529659

2007_532

0773-005

Details and patient eligibility

About

A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).

Enrollment: 170 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is a woman who is 65 years of age or older
• Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population
• Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)<66

Exclusion criteria

• Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
• Patient has a history of certain types of cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups, including a placebo group

MK-0773

Experimental group

Description:

MK-0773

Treatment:

Drug: Comparator: MK-0773

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo