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    Summary
    EudraCT Number:2011-002334-39
    Sponsor's Protocol Code Number:RGH-MD-56
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-05
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-002334-39
    A.3Full title of the trial
    A Double-blind, Placebo-Controlled Evaluation of the Safety and
    Efficacy of Cariprazine in Patients With Bipolar Depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this research study is to gather information about how safe, tolerable, and effective cariprazine is for patients with bipolar depression.
    A.4.1Sponsor's protocol code numberRGH-MD-56
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01396447
    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 SponsorForest Research Institute, 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 supportForest Research Institute United States
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGedeon Richter Plc.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEudraCT_Info@quintiles.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.3.1Product nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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.3.1Product nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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: 3
    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.3.1Product nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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: 4
    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.3.1Product nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    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.IMP: 5
    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.3.1Product nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    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.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, hard
    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 I Disorder Major Depressive Episode
    E.1.1.1Medical condition in easily understood language
    Bipolar 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    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
    To evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo in patients with bipolar depression
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent, signed or thumbprinted (only if allowed by local
    regulations), obtained from the patient before the initiation of any study-specific
    procedures
    2. Male or female patients 18 to 65 years of age, inclusive
    3. Currently meet the DSM-IV-TR criteria for bipolar I disorder without psychotic
    features confirmed by the administration of the Structured Clinical Interview (SCID),
    with a current major depressive episode of at least 4 weeks and not exceeding
    12 months in duration
    4. A verified previous manic or mixed episode. Verification must include one of the following sources;
    ○ Hospital records
    ○ Medical Records
    ○ Patient report corroborated by:
    - family member, caretaker, or previous or current treating clinician with
    confirmation of treatment with an anti-manic or antipsychotic medication
    or
    - confirmation of treatment with an anti-manic or antipsychotic medication
    5. 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
    6. HAMD-17 item 1 score ≥ 2
    7. Clinical Global Impressions–Severity (CGI-S) score ≥ 4
    8. Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of
    childbearing potential only)
    9. Normal physical examination findings, clinical laboratory test results, and
    electrocardiogram (ECG) results or abnormal results that are judged not clinically
    significant by the PI and documented as such in the eCRF
    10. Body mass index between 18 and 40, inclusive
    Inclusion criteria to be assessed at Visit 2 (Baseline)
    11. Continue to meet Visit 1 inclusion criteria
    E.4Principal exclusion criteria
    1. Young Mania Rating Scale (YMRS) total score > 10
    2. Four or more episodes of a mood disturbance (depression, mania, hypomania, or
    mixed state) within the 12 months before Visit 1
    3. Principal DSM-IV-TR–based diagnosis of an axis I disorder other than bipolar
    disorder or any axis I disorder other than bipolar disorder that was the primary focus
    of treatment within 6 months before Visit 1 (secondary diagnoses of comorbid
    generalized anxiety disorder, social anxiety disorder, or specific phobias are
    acceptable)
    4. History of meeting DSM-IV-TR criteria for:
    a. Dementia, amnesic, or other cognitive disorder
    b. Schizophrenia, schizoaffective, or other psychotic disorder
    c. Mental retardation
    5. DSM-IV-TR–based diagnosis of borderline or antisocial personality disorder or other
    axis II disorder of sufficient severity to interfere with participation in this study
    6. History of meeting DSM-IV-TR criteria for alcohol or substance abuse or dependence
    (other than nicotine or caffeine) within the 6 months before Visit 1
    7. Positive result on blood alcohol test or urine drug screen for methadone,
    phencyclidine, amphetamines, or cocaine. (Patients with a positive urine drug screen
    for cannabinoids, barbiturates, opiates, or benzodiazepines may be allowed in the
    study provided that a discussion with the Medical Monitor has occurred and the use
    of such products can be discontinued before participation in the study; medically
    appropriate episodic use [up to 3 days] of narcotic analgesics for acute medical
    indications is allowed during the study; discussion with Medical Monitor is
    recommended).
    8. History of intolerance or hypersensitivity to other drugs of the same class as
    cariprazine or to rescue medications (see Section 9.4.7)
    9. History of nonresponse in the current depressive episode to 2 or more adequate
    treatment trials (at least 6 weeks at an adequate dose based on package insert
    recommendations) with Symbyax (fluoxetine and olanzapine), quetiapine (including
    monotherapy), lithium (including monotherapy) or a mood stabilizer (lithium,
    valproate, lamotrigine, carbamazepine, or oxcarbazepine) in combination with an
    antidepressant. Aripirazole was found ineffective for bipolar depression in 2 large
    controlled trials. It should not be considered as a treatment failure for the history of
    nonresponse exclusion criteria.
    10. At imminent risk of injuring self or others or causing significant damage to property,
    as judged by the PI
    11. Suicide risk, as determined by meeting any of the following criteria:
    ○ A suicide attempt within the past year
    ○ Significant risk, as judged by the PI, based on the psychiatric interview or
    information collected in the Columbia–Suicide Severity Rating Scale (C-SSRS)
    ○ HAMD-17 Item 3 score ≥ 3
    ○ MADRS Item 10 score ≥ 4
    Treatment-Related Criteria:
    12. Electroconvulsive therapy in the 3 months before Visit 1
    13. Previous lack of response to electroconvulsive therapy
    14. Treatment with a depot neuroleptic within 1 treatment cycle before Visit 1
    15. Treatment with clozapine in the past 2 years (exceptions: episodic use of clozapine at
    doses ≤ 150 mg/day for the treatment of insomnia)
    16. Requiring concomitant treatment with any of the prohibited medications,
    supplements, or herbal products listed in Appendix II, including any psychotropic
    drug or any drug with psychotropic activity or with a potentially psychotropic
    component, except for the following (refer to Section 9.4.7):
    ○ Eszopiclone, zolpidem, zolpidem extended-release, zopiclone, chloral hydrate or
    zaleplon for insomnia
    ○ Lorazepam (or oxazepam or diazepam in countries where lorazepam is not readily
    available)
    ○ Diphenhydramine, benztropine or equivalent (eg, trihexyphenidyl), or propranolol
    for EPSs
    17. Prior participation in any investigational study of RGH-188 or cariprazine
    18. Previous treatment with vagus nerve stimulation, transcranial magnetic stimulation,
    or any experimental central nervous system treatment within 6 months before Visit 1
    19. Initiation or termination of psychotherapy for depression within the 3 months
    preceding Visit 1, or plans to initiate, terminate, or change such therapy during the
    course of the study. (Support meetings or counseling [eg, marital counseling] are
    allowed provided they are no more frequent than weekly and do not have treatment of
    depression as their objective)
    20. Initiation or termination of phototherapy within the 2 weeks before screening, or
    plans to initiate same during the course of the study
    Other criteria;
    Positive hepatitis C antibody on screening, unless:
    ○ The condition has been stable for ≥ 1 year,
    ○ The patient is not a candidate for antiviral therapy,
    ○ The hepatitis B core antibody total is nonreactive, and
    ○ The condition is judged by the PI not to interfere with the patient’s participation
    in the study
    Discussion with the medical monitor is required for these cases
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 6 in MADRS total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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) 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 trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Bulgaria
    Canada
    Colombia
    Russian Federation
    Ukraine
    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
    Last Patient, Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 600
    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)
    After the last dose of IP the patient can be titrated to another treatment at the discretion of the Investigator and the patient will enter a 1 week safety follow up period.
    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 Decision2012-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-10
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