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    Summary
    EudraCT Number:2010-024371-12
    Sponsor's Protocol Code Number:CN162-010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-06-30
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-024371-12
    A.3Full title of the trial
    A multicenter, Double-blind 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.
    Estudio de extensión, multicéntrico, doble ciego, de 58 semanas de duración, para evaluar la seguridad y tolerabilidad de BMS-820836 en pacientes con trastorno depresivo mayor resistentes al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Safety and Tolerability of BMS-820836 in the treatment of patients with treatment Resistant Major Depression
    Evaluar la seguridad a largo plazo y tolerabilidad de BMS-820836 en el tratamiento de pacientes con depresión mayor resistente al tratamiento
    A.4.1Sponsor's protocol code numberCN162-010
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Start Up Department
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 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.3.2Product code BMS-820836-03
    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 INNTriple Reuptake Inhibitor
    D.3.9.2Current sponsor codeBMS- 820836-03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.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.IMP: 2
    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.3.2Product code BMS-820836-03
    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 INNTriple Reuptake Inhibitor
    D.3.9.2Current sponsor codeBMS- 820836-03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Subjects with Treatment Resistant Major Depression
    Pacientes con depresión mayor resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Depression
    Depresión
    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 14.0
    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
    The purpose of this study is to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
    El objetivo principal de este estudio es evaluar la seguridad a largo plazo y tolerabilidad de BMS-820836 en pacientes con depresión resistente al tratamiento
    E.2.2Secondary objectives of the trial
    To assess the long term safety and tolerability of 3 target doses of BMS-820836 (0.5, 1 or 2mg/day) in the treatment of subjects with TRD from randomization baseline through 54 weeks of the rollover study as measured by the frequency and severity of AEs, frequency of SAEs and discontination due to AEs.
    Evaluar la seguridad a largo plazo y la tolerabilidad de 3 dosis diana de BMS-820836 (0,5, 1 y 2mg/día) en el tratamiento de pacientes con Depresión Resistente al Tratamiento (DRT) respecto a la aleatorización basal a lo largo de las 54 semanas del estudio de extensión, determinada por la frecuencia y gravedad de los acontecimientos adversos, frecuencia de acontecimientos adversos graves y retiradas por acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
    Pacientes incluidos en el estudio principal que hayan completado CN162006 o CN162007 y otorguen su consentimiento informado para participar en el estudio de extensión.
    E.4Principal exclusion criteria
    1) Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
    2) Patients with a Cardiovascular System Organ Class adverse event(s) occurring in patients study (CN162-006 or CN162-007) that in the investigator judgment is clinically significant and would impact safety of the subject inthe current study (including but not limited to left bundle branch block or prolonged QTc)
    3)In addition, patients should be excluded if they have any laboratory test, vital signs, ECG or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
    1) Pacientes que tengan un riesgo importante de suicidio, a juicio clínico del investigador, por los antecedentes o por la evaluación psiquiátrica sistemática
    2) Pacientes que presenten uno o varios acontecimientos adversos cardiovasculares en el estudio principal (CN162006 o CN162007) que, a juicio del investigador, sean clínicamente importantes y puedan influir en la seguridad del paciente en el presente estudio (incluyendo, pero no sólo limitado, al bloqueo de rama izquierda o prolongación del intervalo QTc).
    3) Pacientes con resultados anormales de las pruebas de laboratorio, las constantes vitales o el ECG o hallazgos clínicos que, a juicio del investigador, sean médicamente importantes porque podrían repercutir en la seguridad del paciente o en la interpretación de los resultados del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is to compare the long-term effect of BMS-820836 through 54 weeks in the change from baseline in blood pressure for patients with depression.
    El objetivo principal de este estudio consiste en comparar el efecto a largo plazo de 3 dosis diana de BMS-820836 (0,5, 1 y 2mg/día) a lo largo de 54 semanas de seguimiento en el cambio respecto a la aleatorización basal de la presión arterial en sedestación media en pacientes con depresión resistente al tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 weeks
    54 semanas
    E.5.2Secondary end point(s)
    Frequency and severity of Adverse Events (AE), frequency of Serious Adverse Events and discontinuations due to AEs.
    frecuencia y gravedad de los acontecimientos adversos, frecuencia de acontecimientos adversos graves y retiradas por acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomization baseline through 54 weeks of the Rollover study
    Desde la aleatorización a lo largo de 54 semanas del estudio de extensión
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    India
    Puerto Rico
    South Africa
    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
    Week 58 will be the last study visit for current study protocol. This visit will be a phone call from the investigator or designee to assess any adverse events the subject may have experienced during the Washout Phase as well as to complete the withdrawal assessments.
    La semana 58 será la última visita del presente protocolo de estudio. Esta visita se realizará mediante una llamada telefónica del investigador o persona designada por él para evaluar los acontecimientos adversos que el paciente pueda haber presentado durante la fase de lavado, así como para completar las evaluaciones de la retirada
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 936
    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)
    At the end of the study, the sponsor will not continue to supply study drug to subjects/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Al final del estudio, el promotor no continuará con el suministro de medicación de estudio a los pacientes/investigadores, a menos que el promotor elija extender el estudio. El investigador debe asegurarse de que el paciente recibe el tratamiento estándar apropiado para la enfermedad del estudio
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-13
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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