A Phase IIa Randomized, Placebo-Controlled Clinical Trial toStudy the Efficacy and Safety of MK-0773 in Patients withSarcopenia - Sarcopenia Study

Phase 1

• Conditions: Sarcopenia; MedDRA version: 9.1Level: LLTClassification code 10063024Term: Sarcopenia

• Registration Number: EUCTR2007-002383-95-FI
• Lead Sponsor: MSD Finland Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2009-10-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Patient is a woman 65 years of age on day of signing the informed consent.
2. Patient has an aLBM/Ht2, measured by DEXA, > 1 SD below the mean of a healthy
young adult population (peak).
3. Patient has self-reported difficulty in climbing 10 steps or walking ¼ mile outside on
level ground without resting.

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

Exclusion Criteria

1. Patient has performed any vigorous exercise (see below) in the 3 months prior to screening (Visit 1) or plans to substantially change the level of physical activity during the study.
2. Patient has untreated depression, psychiatric conditions, respiratory illness, cardiac abnormalities, renal impairment, and/or neuromuscular diseases (Parkinson’s disease, amyotrophic lateral sclerosis, stroke affecting lower extremity function and muscular dystrophy). Patient has conditions that cause significant muscular or joint pain or significantly limit mobility including rheumatoid arthritis, polymyalgia rheumatica, polymyositis, and fibromyalgia. Note: Patients with conditions such as osteoarthritis can participate unless their pain limits them from performing study procedures. Patients with polymyalgia affecting only limited parts of the upper body (i.e., neck, shoulder) can participate in the study.
3. Patient has a history of any form of cancer, with the following exceptions:
a. Adequately treated superficial basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
b. Solid tumor definitively treated without any history of recurrence for at least 5 years prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified