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    Summary
    EudraCT Number:2024-000605-33
    Sponsor's Protocol Code Number:VENL-CAZ-3002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-03-17
    Trial 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 number2024-000605-33
    A.3Full title of the trial
    An open-label, long-term extension, multicenter study to evaluate the safety and efficacy of venlafaxine in Japanese pediatric outpatients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD) who completed study VENL-CAZ-3001.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate safety and efficacy of Venlafaxine in treating MDD or PDD in children who completed VENL-CAZ-3001 study
    A.4.1Sponsor's protocol code numberVENL-CAZ-3002
    A.5.4Other Identifiers
    Name:jRCTNumber:jRCT2031220357
    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 SponsorViatris Pharmaceutical Japan GK
    B.1.3.4CountryJapan
    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 supportViatris Pharmaceutical Japan GK
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViatris Pharmaceutical Japan GK
    B.5.2Functional name of contact pointGlobal Clinical Operation
    B.5.3 Address:
    B.5.3.1Street Address1-3-1,Azabudai,Minato-ku,Tokyo,106-0041
    B.5.3.2Town/ cityTokyo
    B.5.3.3Post code106-0041
    B.5.3.4CountryJapan
    B.5.4Telephone number81356560400
    B.5.6E-mailjapan.communication@viatris.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 Effexor SR
    D.2.1.1.2Name of the Marketing Authorisation holderViatris Pharmaceuticals
    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 Capsule
    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 INNVenlafaxine
    D.3.9.1CAS number 93413-69-5
    D.3.9.4EV Substance CodeSUB00034MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number37.5 to 225
    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
    Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD)
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the safety and tolerability of the long-term use of venlafaxine SR (37.5 to 225 mg/day) in Japanese pediatric patients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD).
    E.2.2Secondary objectives of the trial
    Investigate the efficacy of the long-term use of venlafaxine SR (37.5 to 225 mg/day) in Japanese pediatric patients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Japanese pediatric outpatients who had no serious protocol violations and who completed 8-10 weeks of treatment including tapering period in the placebo-controlled, double-blind comparative study of venlafaxine SR and who tolerated the investigational product well.
    E.4Principal exclusion criteria
    1. Patients with clinically significant abnormalities on physical examinations at approximate Wweek 8-10 Visit of the double-blind comparative study, or patients with clinically significant ECG, clinical laboratory test, or vital sign abnormalities that were recorded before Week 8-10 of the preceding double-blind comparative study and that have not resolved.
    2. Patients identified as CYP2D6 poor metabolizers (PM) during the double-blind comparative study (VENL-CAZ-3001).
    3. Patients clinically determined to be at risk for suicide.
    E.5 End points
    E.5.1Primary end point(s)
    The safety endpoints include:
    • Incidence of adverse events (AEs).
    • Body weight, vital signs, clinical laboratory tests (hematology tests, chemistry tests and urinalysis [qualitative] tests), standard 12-lead electrocardiogram (ECG).
    • Frequency of participants with suicidal ideation or suicidal behavior using Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    Secondary endpoints include:
    • Childhood Depression Rating Scale – Revised (CDRS-R)
    • Clinical Global Impressions-Severity of Illness (CGI-S)
    • Clinical Global Impressions Global Improvement (CGI-I)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    Japan
    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
    The end of the study (EOS) is defined as the date of the last scheduled procedure shown in the SOA for the last participant in the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months48
    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: 145
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 145
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 145
    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)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Viatris Pharmaceutical Japan GK
    G.4.3.4Network Country Japan
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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