A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy andSafety of MK-0773 in Patients with Sarcopenia. - ND

• Conditions: Patients with sarcopenia.; MedDRA version: 9.1Level: LLTClassification code 10063024Term: Sarcopenia

• Registration Number: EUCTR2007-002383-95-IT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

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).
Patient has self-reported difficulty in climbing 10 steps or walking Πmile outside on
level ground without resting.
4) Patient has an SPPB score that is 4-9.
5) Patient is mentally competent - has scored ≥21 on the Folstein?s Estate Examination
(MMSE) at screening (Visit 1) and in the opinion of the Investigator is able to
understand and follow study procedures.
6) Patient is judged to be in satisfactory health based on medical history, physical
examination, ECG, and laboratory screening evaluations.
7) Patient has adequate organ function as indicated by the following laboratory valuesat screening (Visit 1)
8) Patient liver function tests are all within the normal range.
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

Patient has neuromuscular diseases (Parkinson?s disease, amyotrophic lateral
sclerosis, stroke affecting lower extremity function and muscular dystrophy).
2) Patient has rheumatoid arthritis.
3) Patient has conditions that cause significant muscular or joint pain or significantly
limit mobility including 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.
4) Patient has chronic lung disease that limits mobility as a result of respiratory
function.
5) Patient has any other condition which, in the opinion of the investigator or
SPONSOR, may impact the assessment of improved muscle strength and function.
6) Patient has epilepsy, multiple sclerosis, or focal lesions.
7) Patient has axis I psychiatric disorders in the 6 months prior to screening (Visit 1) as
determined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition (DSM-IV).
8) Patient has inadequately treated depression as assessed by a Patient Health
Questionnaire (PHQ-9) score of ≥10 (Appendices 6.2 and 6.3). Note: Patients must
be on stable doses of antidepressants for >60 days to be eligible to participate.
9) Patient has mental or legal incapacitation, or significant emotional problems at the
start of the study.
10) Patient has any other neurological or psychiatric condition that may affect the
patient?s ability to provide informed consent and/or can impact cognitive function.
11) Patient has unstable angina or New York Heart Association (NYHA) Class III or IV
congestive heart failure.

Study & Design

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