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    EudraCT Number:2008-004732-20
    Sponsor's Protocol Code Number:0954-337
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-06-30
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2008-004732-20
    A.3Full title of the trial
    A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK-0954/Losartan Potassium in Pediatric Patients With Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Losartan Potassium in Pediatric Patients With Hypertension
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of MK-0954 in Pediatric Pts with hypertension (ages 6 months - 6 years)
    A.4.1Sponsor's protocol code number0954-337
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/9/2008
    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 supportMerck & Co., Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck & Co., Inc
    B.5.2Functional name of contact pointChun Lam
    B.5.3 Address:
    B.5.3.1Street Address126 E. LINCOLN AVENUE, PO Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065-0900
    B.5.3.4CountryUnited States
    B.5.4Telephone number732594-5027
    B.5.5Fax number732594- 4610
    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 nameLosartan Potassium
    D.3.2Product code MK-0954
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNLosartan Potassium
    D.3.9.1CAS number 124750-99-8
    D.3.9.2Current sponsor codeMK-0954
    D.3.9.3Other descriptive namesame active ingredient as in Cozaar tablets
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    elevated blood pressure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) To define a dose-response relationship for losartan in hypertensive children aged 6 months to 6 years, after a 21-day open-label treatment period (response assessed by change from baseline in mean trough SBP).

    (2) To investigate the safety and tolerability of losartan at doses up to 1.4 mg/kg/day in hypertensive children aged 6 months to 6 years after 12 weeks of treatment.

    E.2.2Secondary objectives of the trial
    (1) To define a dose-response relationship for losartan in hypertensive children aged 6 months to 6 years, after a 21-day open-label treatment period (response as assessed by change from baseline in mean trough DBP).

    (2) To estimate the change from baseline in SBP in each dose regimen by Day 21.

    (3) To estimate the change from baseline in DBP in each dose regimen by Day 21.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female from 6 months to 6 years of age. (Patient has not reached 7th birthday at time of randomization).

    Patient age refers to chronological age not corrected age as in the prematurely born
    infant population

    2. Patient is determined to be hypertensive according to one of the following criteria:
    Patient is 6 months to <1 year old with a mean systolic blood pressure ≥ 95th
    percentile based on gender and age.
    Patient is ≥1 year old with a mean systolic and/or diastolic blood pressure ≥ 95th
    percentile based on gender, height and age.
    Patient has co-morbidities or evidence of end organ damage with:
    a. mean systolic blood pressure ≥ 90th percentile (6 month to <1 year old) based on
    gender and age.
    b. mean systolic and/or diastolic blood pressure ≥ 90th percentile (≥1 year old)
    based on gender, height, and age.

    3. Informed parental consent has been obtained. Patient assent (when feasible) has been obtained as required by local regulations.
    E.4Principal exclusion criteria
    1. Patient has a history of severe or symptomatic hypertension (e.g.hypertensioninduced seizures, stroke, encephalopathy) within 1 year of Visit 1 including patients whose SBP or DBP >99th percentile for gender/age/height plus 10 mm Hg.

    2. Patient has a history of clinically significant heart failure, rhythm disturbance or
    cardiomyopathy, or hemodynamically significant obstructive valvular disease.

    3. Patient has clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease.

    4. Patient has a known history of uncorrected coarctation of the aorta, bilateral renal
    artery stenosis, or renal artery stenosis to a single kidney.

    5. Patient has a glomerular filtration rate of <30 ml/min/1.73m2 as determined by the
    Schwartz Formula, based on the baseline serum creatinine:

    GFR = 0.55 x height (cm)/Serum creatinine (mg/dL)

    [Note: For patients <1 year of age, the constant 0.45 will be used in place of 0.55.
    For patients <1 year of age who were born with low birth weight (regardless of
    gestational age), the constant 0.33 will be used in place of 0.55.]

    Low birth weight is defined as <2500 grams (2.5 kilograms).

    The constant that is used for an individual patient at the start of the study will be used for that patient for the duration of the base study. During the extension phase, the constant appropriate for the child’s chronological age will be used.

    6. Patient has clinically significant laboratory values (as determined by the investigator) at Visit 1 outside of the established normal range including but not limited to any of the following parameters:
    SGOT (AST) or SGPT (ALT) >2X the upper limit of normal
    Total bilirubin or direct bilirubin >2X the upper limit of normal
    White blood cell count <3000/mm3
    Platelet count <100,000/mm3
    Serum potassium ≥5.5 mEq/L (≥5.0 mEq/L if concomitantly
    on ACE-inhibitor)
    Serum sodium ≤130 mEq/L

    7. Patient has a known sensitivity to losartan or other ARB, or any history of
    angioneurotic edema.

    8. Patient or patient’s guardian who, in the opinion of the investigator, will not fully
    cooperate, keep appointments, or who has been generally unreliable.

    9. Patient has any other factors limiting participation (e.g., significant, concurrent, or
    life-threatening diseases such as cancer, or mental incapacitation).

    10. Patient is currently being treated with any of the following:
    angiotensin II type I receptor blocker (ARB)
    cyclosporine or tacrolimus (FK-506)
    potassium-sparing diuretics (triamterene, amiloride, spironolactone and
    herbal supplements
    potassium supplements
    chronic analgesics (NSAIDS, opioids, acetaminophen, aspirin)

    11. Patient has used any investigational compounds within 30 days of Visit 1.

    12. Patient has started any new concomitant antihypertensive medications within 30 days of Visit 1. Dosage of concomitant antihypertensive medications should be stable for 30 days before Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    Change in sitting systolic blood pressure (SBP) after 21 days of treatment (the end of the 1st dose period) compared to baseline as a function of dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 21 days of treatment
    E.5.2Secondary end point(s)
    Change in sitting diastolic blood pressure (SBP) after 21 days of treatment (the end of the 1st dose period) compared to baseline as a function of dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 21 days of treatment
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    No comparator. Patients randomised to one of three starting doses of open label losartan.
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Russian Federation
    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
    In this study, end of trial will be when last patient randomized has final visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F. of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F. of subjects incapable of giving consent
    Children aged 6 months to 6 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    Expected normal treatment for patients aged 6 months to 6 years with hypertension.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Philippines
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