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    Summary
    EudraCT Number:2007-002383-95
    Sponsor's Protocol Code Number:0773-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-01
    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 ConcernedUK - MHRA
    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
    Sarcopenia Study
    A.4.1Sponsor's protocol code number0773-005
    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.3.1Product nameMK-0773
    D.3.2Product code MK-0773
    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.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeMK-0773
    D.3.9.3Other descriptive nameMK-0773
    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
    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
    The main objective of this Phase IIA POC study is to evaluate the efficacy, safety, and
    tolerability of MK-0773 in elderly sarcopenic women.
    1) 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
    1) 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
    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, or an AM-PAC physical movement score <66.
    4. Patient has an SPPB score that is 1-9.
    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 values (Table 2-1) at 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 & muscular dystrophy), rheumatoid arthritis, conditions causing significant muscular/joint pain or significantly limits mobility (e.g. polymyalgia rheumatica, polymyositis, & fibromyalgia). Patient with conditions like osteoarthritis can participate unless pain limits performing study procedures. Patients with polymyalgia affecting only limited parts of upper body (i.e. neck, shoulder) can participate.
    •chronic lung disease limiting mobility due to respiratory function, or has another condition that impacts assessing improved muscle strength/ function, or has epilepsy, multiple sclerosis or focal lesions.
    •axis I psychiatric disorders in the 6 months prior to screening
    •inadequately treated depression or mental/legal incapacitation, or significant emotional problems at study start.
    •another neurological/psychiatric condition affecting ability to give informed consent and/or can impact cognitive function.
    •unstable angina or NYHA Class III or IV congestive heart failure or has uncontrolled hypertension (i.e., sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mm Hg).
    •clinically significant postural hypotension (i.e., drop of 20 mm Hg in systolic blood pressure or increase of 20 beats/minute after 5 mins standing).
    •a history of marked baseline prolongation of QT/QTc interval, or additional risk factors for Torsades de Pointes, or concomitant use of medications prolonging QT/QTc interval.
    •symptomatic peripheral arteriovascular disease likely to affect patients' mobility & ability to perform study procedures
    •significant cardiovascular disease, including any known history of myocardial infarction.
    •history of any cancer, except: adequately treated superficial basal or squamous cell carcinoma of skin or cervical carcinoma in situ; or solid tumor definitively treated without history of recurrence for at least 5 years prior to screening.
    •taken anabolic steroids, dehydroepiandrosterone, androstenedione, any drug altering testosterone metabolism within 12 months before screening or rGH in the 12 months prior to screening. Tamoxifen also prohibited due to its suppressive effects on androgen levels.
    •taken glucocorticoids at supraphysiological doses within 2 months before screening . Inhaled & topical glucocorticoids not excluded.
    •taken strong inhibitor/inducer of CYP3A4, within 2 weeks before screening or anticipates using these during study.
    •taken neuroleptic medications in the 6 months prior to screening. Hypnotics not excluded. Taking parathyroid hormone or vitamin D active metabolites.
    •Cushing's syndrome or disease not cured for at least 12 months, or has Addison's disease.
    •had bilateral adrenalectomy or any vestibular disorders.
    •requires walking aid to perform study procedures. Patients using walking aids are allowed in the study; however they must be able to perform most study procedures without an assistive device. It is permissible for the patient to use a walking device for the SPPB if she's not comfortable performing walk test without assistive device.
    •malabsorption syndrome or infections/ conditions predisposing to immunological suppression or immunodeficiency, including HIV infection.
    •hirsutism, and / or patient has severe facial acne or patient has androgenetic alopecia.
    •polycythemia, or untreated severe obstructive sleep apnoea, or uncontrolled diabetes, or HDL <40 mg/dL, or albumin <3.0 g/dL at the time of screening.
    •experienced unintentional weight change of >5% of the oldest recorded weight within the one year prior to screening or has a BMI >35.
    •primary hyperparathyroidism or active thyroid disease, demonstrated by abnormal serum TSH and free T4 at screening.
    •experienced acute illness within 30 days before screening affecting lower extremity function/patient's ability to participate in study.
    •performed vigorous exercise in 3 months before screening or plans to substantially change level of physical activity during study.
    •is unable to adhere to study procedures & dosing regimen possibly be due to untreated visual/hearing impairments; cannot swallow large pills; cannot keep appointments or plans to relocate during the study; inability to perform the one repetition maximum bilateral leg press procedure at Visit 1
    •is at time of signing informed consent, a user of recreational/illicit drugs, or has recent history of drug/alcohol abuse/dependence.
    •a concurrent disease, or laboratory abnormality which would make patient inappropriate for entry into study.
    •is unable to adhere to the study procedures and dosing regimen which may be due to inability to comply with study drug regimen.
    E.5 End points
    E.5.1Primary end point(s)
    This is a 6-month study. The muscle strength determined by bilateral leg press will be measured at screening, randomization (Month 0), and Months 1, 3, and 6; the lean body mass (LBM) will be measured using DEXA at screening, Months 0, 3, and 6. The primary endpoints of interest will be the change from baseline in bilateral leg press and total lean body mass (LBM) at Month 6.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    An interim efficacy analysis will be conducted when 50% of expected completers
    (approximately 40 per treatment group) complete the 6 month study. The study will be stopped if the treatment effects on both LBM and leg press are negative relative to placebo (point estimates of differences between MK-0773 and placebo are less than 0. The variability of the primary endpoints will also be checked and the sample size may be increased to ensure the study has sufficient power.
    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 months
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is discussion regarding an exercise extension to the protocol; however, the details have not been finalized. Otherwise, no plans for treatment or care are established once a patient completes the trial.
    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 Decision2007-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-09
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