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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00529659 |
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Date of registration:
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11/09/2007 |
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Primary sponsor: |
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Public title:
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A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
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Scientific title:
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A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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170 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00529659 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Chile
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Colombia
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Denmark
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Finland
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France
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Hong Kong
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Israel
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Italy
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Mexico
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New Zealand
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Norway
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Peru
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South Africa
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion 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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sarcopenia
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Intervention(s)
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Drug: Comparator: MK-0773
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Drug: Comparator: Placebo
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Primary Outcome(s)
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Change From Baseline in Bilateral Leg Press (BLP) Measurement
[Time Frame: Baseline, Month 6]
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Change From Baseline in Participant Lean Body Mass
[Time Frame: Baseline, Month 6]
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Secondary Outcome(s)
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Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
[Time Frame: Baseline, Month 6]
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Change From Baseline in Participant Gait Speed
[Time Frame: Baseline, Month 6]
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Change From Baseline in Participant Short Physical Performance Battery (SPPB)
[Time Frame: Baseline, Month 6]
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Change From Baseline in Stair Climbing Power
[Time Frame: Baseline, Month 6]
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Secondary ID(s)
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2007_532
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MK-0773-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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