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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003328-30
    Sponsor's Protocol Code Number:CS0866-A-U102
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-27
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-003328-30
    A.3Full title of the trial
    An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olmesartan Pediatric Pharmacokinetic (PK) Study
    A.4.1Sponsor's protocol code numberCS0866-A-U102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00151814
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Sankyo Pharma Development
    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 supportDaiichi Sankyo Pharma Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross
    B.5.3.3Post codeSL90BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441753482800
    B.5.6E-mailinfo@dsd-eu.com
    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 Yes
    D.2.1.1.1Trade name Benicar
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNOlmesartan Medoxomil
    D.3.9.1CAS number 144689-63-4
    D.3.9.2Current sponsor codeCS-0866
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    Hypertension
    E.1.1.1Medical condition in easily understood language
    High 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 18.0
    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
    The primary objective of this study was to determine the single-dose pharmacokinetics (PK) of olmesartan medoxomil (OM) in pediatric subjects with hypertension between the ages of 12 months to 16 years
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 12 months to 16 years, inclusive
    2. Signed parental/guardian informed consent provided and assent from the subject if he/she was ≥ 7 years old, or as required by the local IRB.
    3. Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2, estimated using the Schwartz equation
    4. Sexually active females of child-bearing potential must have been practicing an acceptable method of birth control as defined as oral, injectable, or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide.
    5. Negative serum beta-hCG at Screening and at administration (females of child bearing potential only)
    6. Hypertension defined as one of the following:
    - Current treatment for hypertension
    - Systolic blood pressure (SBP) ≥ 95th percentile
    - SBP or diastolic blood pressure (DBP) ≥ 90th percentile if diabetic or with a family history of hypertension
    E.4Principal exclusion criteria
    1. Clinically significant cardiac, gastrointestinal, hematological, hepatic or hepatobiliary, neurological, or pulmonary (except asthma) disorder
    2. History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurological findings within 2 years prior to Screening
    3. Current treatment with more than 2 antihypertensive medications
    4. Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
    5. Serum albumin < 2.5 g/dL
    6. Major organ or bone marrow transplantation except for kidney transplantation at least 6 months prior to Screening with stable renal function meeting the inclusion criteria
    7. History of classic allergic response to the angiotensin II receptor antagonist class of drugs
    8. Pregnancy or current lactation
    9. Pertinent electrolyte disorders (serum sodium ≤ 130 mEq/L, potassium ≥ 5.5 mEq/L, for example)
    10. Significant systemic disease that, in the judgment of the investigator, would disqualify the subject for this study
    11. History of drug or alcohol abuse
    12. Current treatment with any of the following medications: anticonvulsants, bile acid sequestrants, metoclopramide, major psychotropic agents, glucocorticosteroids (high-dose regimens, i.e., > 1 mg/kg given daily), prokinetic agents such as bethanechol or cisapride, antibiotics, except as approved by the Sponsor, any drug that might interfere with the absorption of OM
    13. Any laboratory value at Screening outside the range of normal limits for the appropriate age group unless approved by the Principal Investigator and Sponsor
    14. History of malignancy or exposure to cytotoxic agents within the last 6 months
    15. Participation in another investigational new drug research study in the previous 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic endpoints
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Paediatric PK
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months4
    E.8.9.2In all countries concerned by the trial days9
    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: 24
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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.3.3.6.1Details of subjects incapable of giving consent
    Written informed consent was obtained from each subject’s parent/guardian. In addition to parental consent, assent was obtained from subjects 7 years of age and older, or as required by the local IRB.
    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 24
    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)
    None
    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: United States
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