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    Summary
    EudraCT Number:2015-003329-32
    Sponsor's Protocol Code Number:CS0866-A-U301
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-28
    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 number2015-003329-32
    A.3Full title of the trial
    Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
    A.4.1Sponsor's protocol code numberCS0866-A-U301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00151775
    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 number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    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 the study was to evaluate the efficacy and safety of OM in subjects 6 to 16 years of age with high BP or hypertension.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Subjects 6 to 16 Years of Age
    1. Provided informed consent and agreed to attend all clinic visits. (An informed consent form [ICF] was approved by the IRB/IEC and was signed by the parent/legal guardian.)
    2. Subject assented to the study.
    3. Female or male subject who was 6 years to < 17 years of age and weighing 20 kg. (Note, a subject was considered 16 years of age until the day before their 17th birthday at the Screening Visit.)
    4. Adolescent females taking oral contraceptives had to be on therapy for at least 3 months before Screening. Not applicable to male subjects.
    5. Post-menarchal females had to have a negative urine pregnancy test result within 72 hours prior to receiving study drug. These subjects were not to become pregnant for the duration of the study and were to use acceptable contraception. Not applicable to male subjects.
    6. Hypertension defined as a SeSBP measuring at or above the 95th percentile (90th percentile for diabetics, subjects with glomerular kidney disease, or subjects with a family history of hypertension) for age, gender, and height while off any antihypertension medication. Subjects had to meet this requirement by Visit 1.2.
    7. Negative hepatitis B and C tests and a negative human immunodeficiency virus (HIV) antibody test.
    8. Subject was a non-smoker or had not smoked for the past month.
    Inclusion Criteria for Subjects 1 to 5 Years of Age
    1. Provided informed consent and agreed to attend all clinic visits. (An ICF was approved by the IRB/IEC and was signed by the parent/ legal guardian).
    2. Female or male subject ≥ 1 year to < 6 years of age and had a weight of ≥ 5 kg. Note: A subject was considered 5 years of age until the day before their 6th birthday at the Screening Visit.
    3. Hypertension as defined by a SeSBP measuring at or above the 95th percentile (90th percentile for diabetics, subjects with glomerular kidney disease, or subjects with a family history of hypertension) for age, gender, and height while off any antihypertensive medication. Subjects could continue their CCB and/or diuretic therapy if they satisfied the SeSBP criteria while on their medications. Subjects must have met this requirement by Visit 1.2.
    4. Negative hepatitis B and C tests and negative HIV antibody test.
    5. Subject was a non-smoker.
    E.4Principal exclusion criteria
    1. Had any clinically relevant unstable medical condition or chronic disease other than those associated with hypertension.
    2. Had significant clinical illness within 10 days prior to receiving the first dose of study medication (Day 1, Visit 2.0 of Period II).
    3. Had clinically relevant abnormality of the hepatic system or a history of malabsorption or previous gastrointestinal surgery that could affect drug absorption or metabolism.
    4. Had any of the following clinical laboratory abnormalities:
    -an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that was > 2 times the upper limit of the reference range;
    -a total bilirubin or direct bilirubin that was > 2 times the upper limit of the reference range;
    -a creatinine clearance that was < 25 mL/min/1.73m^2 (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]);
    -a hemoglobin that was < 9 g/dL;
    -a white blood cell (WBC) count that was < 3000/mm^3;
    -a platelet count that was < 100,000/ mm^3;
    -a serum potassium that was > upper limit of the reference range;
    -a serum albumin that was < 2.5 g/dL.
    5. Had known hypersensitivity to OM or its excipients, or other ACE inhibitors or angiotensin receptor blocking drugs.
    6. Had taken an investigational drug or participated in an investigational study within 30 days prior to study drug administration.
    7. Taking excluded medication (See Section 6.4.7).
    8. Consumed more than 180 mg of caffeine per day (or seven 6-ounce cans of cola drink) and/or was unable or unwilling to refrain from ingesting caffeine or xanthine-containing beverages (tea, coffee, cola) from 24 hours prior to dosing through study completion.
    9. Had malignant hypertension (i.e., hypertension associated with symptoms of malignant hypertension per investigator’s judgment; or SeSBP and/or SeDBP that was >2 SDs above the 99th percentile [SeSBP that was 22 mm Hg above the 99th percentile and SeDBP that was 12 mm Hg above the 99th percentile] for subject’s age/height/gender).
    10. Had any condition or reason that caused the investigator to feel that the subject was not suited for the study.
    11. Required more than 2 medications for treatment of hypertension.
    12. Had a history of congestive heart failure, obstructive valvular disease, or cardiomyopathy.
    13. Had uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney.
    14. Had a renal transplant within the previous 6 months or, if the subject had a transplant more than 6 months before, was not on a stable anti-rejection therapy regimen for at least 3 months prior to screening.
    15. Had severe nephritic syndrome not in remission.
    E.5 End points
    E.5.1Primary end point(s)
    SeSBP and SeDBP at the end of Period II.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 weeks after randomisation
    E.5.2Secondary end point(s)
    SeSBP and SeDBP at the end of Period III.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 weeks after randomisation
    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 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.7.1.3.1Other 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 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 Yes
    E.8.2.3.1Comparator description
    High and Low dose of IMP
    E.8.2.4Number of treatment arms in the trial2
    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
    Argentina
    Chile
    Colombia
    Costa Rica
    Kenya
    South Africa
    Uganda
    United States
    Zambia
    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 years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days18
    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: 362
    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.1.1.4.1Number of subjects for this age range: 9
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 158
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 195
    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
    Subjects, unable to give informed consent, demonstrated assent to the procedures, and signed informed consent was obtained from their parent(s) or legal guardian(s).
    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 362
    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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