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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-0773

Group Type EXPERIMENTAL

Comparator: MK-0773

Intervention Type DRUG

MK-0773 50 mg tablets twice daily, 6 month treatment period

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets twice daily, 6 month treatment period

Interventions

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Comparator: MK-0773

MK-0773 50 mg tablets twice daily, 6 month treatment period

Intervention Type DRUG

Comparator: Placebo

Placebo tablets twice daily, 6 month treatment period

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No