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    Summary
    EudraCT Number:2007-002383-95
    Sponsor's Protocol Code Number:MK0773-005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002383-95
    A.3Full title of the trial
    A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and
    Safety of MK-0773 in Patients with Sarcopenia.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberMK0773-005
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MK0773
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK0773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with sarcopenia.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063024
    E.1.2Term Sarcopenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of 6 months of treatment with MK-0773 on muscle strength, as
    determined by bilateral leg press, relative to placebo.
    2) To assess the effect of 6 months of treatment with MK-0773 on total lean body mass
    (LBM), as determined by DEXA, relative to placebo.
    3) To assess the safety and tolerability of 6 months of treatment with MK-0773.
    E.2.2Secondary objectives of the trial
    To assess the effect of 6 months of treatment with MK-0773 on muscle power, as
    determined by stair climbing power, relative to placebo.
    2) To evaluate the effect of 6 months of treatment with MK-0773 on mediolateral body
    sway with eyes open, relative to placebo.
    3) To evaluate the effect of 6 months of treatment with MK-0773 on the short physical
    performance battery (SPPB) tests and its component, gait speed.
    4) To evaluate the effect of 6 month of treatment with MK-0773 on self reported
    physical function (AM-PAC).
    5) To perform endpoint validation analysis on performance-based and self-reported
    physical performance measures to identify optimal functional endpoints for Phase IIb
    and Phase III studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient is a woman &#8805;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 &#8805;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.
    E.4Principal 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 &#8805;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.
    E.5 End points
    E.5.1Primary end point(s)
    The goal of this analysis is to estimate the relationship between lower extremity strength
    and performance-based and self-reported measures of physical performance in older
    women with sarcopenia who have mobility limitations.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 200
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-01
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