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    Summary
    EudraCT Number:2004-000990-78
    Sponsor's Protocol Code Number:10413
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000990-78
    A.3Full title of the trial
    A Double-Blind, Multicentre, Randomised, Parallel-group, Placebo-controlled Study Assessing the Efficacy and Safety of Escitalopram in Post-Myocardial Infarction Patients Suffering from Depressive Symptoms.
    A.4.1Sponsor's protocol code number10413
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Cipralex
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameCipralex
    D.3.2Product code Lu 26-054
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEscitalopram
    D.3.9.2Current sponsor codeLu 26-054
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depressive symptoms in post myocardial infarction patients
    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 efficacy and safety of 8 weeks of escitalopram treatment on depressive symptoms in post myocardial infarction outpatients.
    E.2.2Secondary objectives of the trial
    During a 24-week study period:
    to assess the efficacy of escitalopram
    to assess the safety and tolerability of escitalopram
    to assess quality of life
    to evaluate resource utilization
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The patient is able to read and understand the patient information sheet.
    2. Prior to any screening procedures, the patient must have signed the informed consent form.
    3. Male or female outpatient aged from 40 to 75 years (extremes included).
    4. A score above or equal to 20 on the SCL-90-R Depression subscale (13 items).
    5. Admission for chest pain (or other MI symptom) with a diagnosis of evolving MI not less than 3 weeks and not more than 24 weeks prior to screening, as evidenced by either a or b:
    a.Elevation of biochemical markers of myocardial infarction (troponin, CK/MB).
    b.ECG changes that are unequivocally consistent with an acute, evolving MI, i.e.
    development of significant Q-wave in at least two continuous leads.
    6. On the basis of a physical examination, medical history, ECG, and the results of blood biochemistry and haematology tests carried out at the screening visit, the patient is, in the investigator’s opinion, healthy, otherwise than what is part of the myocardial infarction and its sequelea.
    E.4Principal exclusion criteria
    1. Patients who have previously participated in this study.
    2. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within 3 weeks of screening or CABG or PTCA during the duration of the study.
    3. Known Class IV rating as defined by the Canadian Cardiovascular Society (CCS) Classification for angina, based on investigator judgment or medical chart.
    4. Known Class IV rating as defined by the Congestive Heart Failure Classification of the New York Heart Association (NYHA), based on investigator judgment or medical chart.
    5. Ongoing myocardial ischemia diagnosed with presence of ST-segment elevation or ST-segment depression on screening visit ECG.
    6. Cardiac arrhythmias (except atrial fibrillation) necessitating other anti-arrhythmic treatment than beta-blockers or calcium-channel blockers.
    7. Uncontrolled high blood pressure: diastolic above or equal to 100 mmHg or systolic above or equal to 180 mmHg.
    8. Bipolar I and II disorders, major depressive episode with psychotic features or evidence of substance abuse or dependency during the previous 12 months based on investigator judgment or medical chart.
    9. Patients with a baseline MADRS total score above or equal to 40.
    10. Serious suicide risk based on investigator judgment or a score above or equal to 3 on item 15 of the SCL-90-R or a score above or equal to 5 on item 10 of the MADRS.
    11. Use of disallowed recent or concomitant medications or treatments:
    ·IMAO or RIMA within 2 weeks prior to screening.
    ·Fluoxetine within 5 weeks and other SSRIs or TCAs or SNRIs within the past 2 weeks prior to screening.
    ·Herbal remedies, which are psychoactive (including St-John’s Wort, S-adenosylmethionine or SAMe, kava kava, valerian, ginkgo biloba) within 2 weeks prior to screening.
    ·Tryptophan within 2 weeks prior to screening.
    ·Any drug used for the augmentation of antidepressant action within 2 weeks prior to screening.
    ·Any other anti-depressants within the 2 weeks prior to screening.
    ·Mood stabilisers/antimanic drugs/anticonsulvants (e.g. lithium, lamotrigine, valproic acid, gabapentine, carbamazepine, phenytoin) within the 2 weeks prior to screening.
    ·Oral antipsychotics in the 2 weeks or depot anti-psychotics in the 6 months prior to screening.
    ·Electroconvulsive therapy (ECT) within the 6 months prior to screening.
    ·Benzodiazepines are only allowed if the patient is on stable treatment prior to screening with a maximum daily dose of diazepam 10 mg (or its equivalent). This dose should remain fixed for the duration of the study.
    ·During the course of the study period, if needed, the use of hypnotics is allowed (zolpidem, zaleplon or zopiclone) for a maximum of 3 evenings per week.
    ·Dopamine antagonists (e.g. metoclopramide) for any indication within 2 weeks prior to screening.
    ·Serotonergic agonists (e.g. triptans) within 2 weeks prior to screening.
    ·Any other drugs with potential psychotropic effects within 2 weeks prior to screening.
    12. Patient was receiving, within 4 weeks prior to screening, formal behaviour therapy or systematic psychotherapy, or was planning to initiate such therapy during the study.
    13. The patient has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.
    14. The patient has laboratory values outside the normal ranges and considered by the investigator to be clinically significant.
    15. For female patients of child-bearing potential:
    ·Pregnant or breast-feeding.
    ·Lack of adequate contraception (one of the following methods is acceptable: oral / systemic, surgical sterilisation, intra-uterine device (IUD), diaphragm in combination with spermicide or condom in combination with spermicide or vasectomy).
    ·Positive pregnancy test at screening.
    16. Patients, who have a disease or take medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy of escitalopram.
    17. Lack of response to a previous trial of citalopram or escitalopram.
    18. Known drug intolerance or hypersensitivity to citalopram or escitalopram.
    19. Participation in other clinical studies (including medications and medical devices) within 30 days prior to screening.
    20. The patient is unable or unwilling to comply with the study requirements.
    21. The patient has a history of severe drug allergy or hypersensitivity.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 8 in SCL-90-R depression subscale score (LOCF)
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life assessment
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Database lock. There will be a certain time needed to allow retrospective ECG reading according to protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 290
    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)
    N/A
    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 Decision2004-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
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