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    The EU Clinical Trials Register currently displays   39211   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000607-15
    Sponsor's Protocol Code Number:A1281133
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-09
    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 number2015-000607-15
    A.3Full title of the trial
    26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
    A.4.1Sponsor's protocol code numberA1281133
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00265330
    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 SponsorPfizer 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 Geodon/Zeldox
    D.2.1.1.2Name of the Marketing Authorisation holderpfizer 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.3.1Product nameZiprasidone HCl
    D.3.2Product code CP-88059-1
    D.3.4Pharmaceutical form Capsule
    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 INNZIPRASIDONE
    D.3.9.1CAS number 146939-27-7
    D.3.9.4EV Substance CodeSUB00168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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 placeboCapsule
    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
    Bipolar Disorder
    E.1.1.1Medical condition in easily understood language
    Mental condition marked by alternating periods of elation and depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of oral ziprasidone (40-80 milligram [mg] twice a day[BID]) during long-term, open-label administration in children and adolescents with Bipolar I Disorder - Single Manic Episode; Bipolar I Disorder – Most Recent Episode Manic, or Bipolar I Disorder – Most Recent Episode Mixed
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
    2. The subjects must have received study medication in Study A1281132. In general, subjects should have completed at least 3 weeks of double-blind treatment before entering this open-label extension. However, subjects who have insufficient treatment response and have reached their maximum tolerated dose may enroll in the open-label extension as early as 1 week after the end of their titration.
    3. In the investigator’s opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double-blind study (ie, in the opinion of the investigator, the benefits that the subject is likely to derive from continued participation must outweigh the risks).
    4.Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:
    • Are instructed and agree to avoid pregnancy during the study.
    • Have a negative serum pregnancy test (-hCG) at the baseline visit.
    • Use one of the following birth control methods:
    • an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), transdermal hormonal contraceptive (Ortho-Evra), or an injectable contraceptive (eg, Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or
    • a barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; or abstinence during the preceding double-blind study and intention to abstain from sexual activity throughout this extension study.
    E.4Principal exclusion criteria
    1. Subjects who experienced a serious adverse event considered related to study medication during the preceding double-blind trial.
    2. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persisting QT interval corrected using Fridericia’s formula (QTcF) greater than or equal to () 460 millisecond (msec) or increase from baseline of QTcF  60 msec) during the preceding study (subjects with an increase in QTcF of  60 msec but with QTcF less than or equal to (≤) 400 msec will be reviewed on a case-by-case basis by the sponsor for possible inclusion in the study).
    3. Subjects requiring any medications not allowed by the Concomitant Medication Table.
    4. Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
    5. Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the CDRS-R, or who are otherwise judged by the investigator as being at imminent risk of suicide.
    6. Subjects who are judged by the investigator as being at imminent risk of homicide during the study.
    E.5 End points
    E.5.1Primary end point(s)
    - Young Mania Rating Scale (YMRS) Total Score Change From Baseline
    - Clinical Global Impression of Severity (CGI-S) Change From Baseline
    - Incidence of Lab Abnormalities
    - Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
    - Change in Hormones
    - Mean Change From Baseline in Supine Systolic Blood Pressure
    - Mean Change From Baseline in Supine Diastolic Blood Pressure
    - Mean Change From Baseline in Supine Pulse Rates
    - Mean Change From Baseline in Standing Systolic Blood Pressure
    - Mean Change From Baseline in Standing Diastolic Blood Pressure
    - Mean Change From Baseline in Standing Pulse Rates
    - Mean Change From Baseline for Body Weight
    - Mean Change From Baseline for Body Mass Index (BMI) Z-Score
    - Body Mass Index (BMI) Z-score Frequency
    - Body Mass Index (BMI) Z-score Frequency
    - Mean Change From Baseline for QTcF Intervals
    - Frequency of Largest Categorical Increases in QTcF for Males
    - Frequency of Largest Categorical Increases in QTcF for Females
    - Frequency of Largest Categorical Increases in QTcF - All Subjects
    E.5.1.1Timepoint(s) of evaluation of this end point
    - baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
    - baseline and 26 Weeks; 26 Weeks LOCF
    - Week 26
    - Week 6, Week 26
    - Week 6, Week 26
    - Week 6, Week 26
    - Week 1 through Week 26
    - Week 1 through Week 26
    - Week 1 through Week 26
    - Week 1 through Week 26
    - Week 1 through Week 26
    - Week 1 through Week 26
    - Week 6, Week 26
    - Week 6, 26, early termination
    - Week 6
    - Week 26
    - Baseline to Week 26 (end of study)
    - Week 26 (end of study)
    - Week 26 (end of study)
    - Week 26 (end of study)
    E.5.2Secondary end point(s)
    NONE
    E.5.2.1Timepoint(s) of evaluation of this end point
    NONE
    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 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 Yes
    E.8.1.2Open No
    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
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days8
    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: 162
    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: 41
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    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 Yes
    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
    Children and Adolescents aged 2 to 17 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 162
    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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