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    Summary
    EudraCT Number:2008-007093-37
    Sponsor's Protocol Code Number:ACV20616
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-25
    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
    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 number2008-007093-37
    A.3Full title of the trial
    CLEOPATRA: Eficacia clínica de Pentalong® en pacientes con angina de pecho estable después de 12 semanas de administración sistemática: ensayo aleatorizado, doble ciego, controlado con placebo. Clinical efficacy of Pentalong® in stable Angina patients after 12 Weeks of routine administration:a randomised, double-blind, placebo-controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    CLEOPATRA
    A.4.1Sponsor's protocol code numberACV20616
    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 SponsorActavis Deutschland GmbH & Co.Kg
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Pentalong®
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePentalong®
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form 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 INNpentaerythritol tetranitrate
    D.3.9.1CAS number 78 11-5
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboTablet
    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
    Angina de pecho estable inducida por el esfuerzo. Stable, effort-induced angina pectoris.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049194
    E.1.2Term Stable angina pectoris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este ensayo es demostrar la superioridad de PETN con respecto a placebo en el tratamiento de pacientes con angina de pecho estable inducida por el esfuerzo que reciben un tratamiento antianginoso de fondo en un ensayo moderno que cumple las normas reguladoras.The primary objective of this trial is to show superiority of PETN over placebo in the treatment of patients with stable, effort-induced angina pectoris receiving anti-anginal background therapy in a modern, regulatory guideline compliant trial.
    E.2.2Secondary objectives of the trial
    Un objetivo secundario es evaluar la seguridad y la tolerabilidad de 80 mg de PETN bid (2 veces al día) para el tratamiento de pacientes adultos con angina de pecho estable inducida por el esfuerzo.A secondary objective is to evaluate the safety and tolerability of PETN 80 mg bid for treatment of adult subjects with stable, effort-induced angina pectoris.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Al final del período de preparación deben satisfacerse los siguientes criterios de inclusión:
    1. Segunda PTE de clasificación cumpliendo todos los criterios siguientes:
    Criterios de positividad: aparición de limitación por angina y depresión del segmento ST de 1 mm como mínimo en comparación con el ECG en reposo (horizontal o en pendiente descendente que dura como mínimo 0,08 segundos después del punto J, en tres complejos consecutivos como mínimo) entre 2,5 y 12 minutos desde el inicio con protocolo modificado de Bruce con ergómetro de tapiz rodante. Si la PTE es interrumpida antes de alcanzarse la positividad por cualquier motivo, el paciente no será incluido.
    Criterios de estabilidad: La diferencia entre los resultados de la PTE medidos en la selección (día -7) y la inclusión (día 0) tiene que ser menor que el 20% del valor del día 0.
    2. Al menos 4 ataques de angina en el período de las 4 semanas anteriores a la aleatorización.
    3. Cumplimiento del tratamiento durante el período de preparación, esto es, placebo además del tratamiento de fondo (cumplimiento calculado del 85% como mínimo, además, el paciente no debe haber perdido más de una dosis diaria completa).
    At the end of the run-in period the following inclusion criteria must be fulfilled:
    1. Second qualifying ETT meeting all of the following criteria:
    - Positivity criteria: occurrence of limiting angina and ST-segment depression of at least 1 mm as compared to resting ECG, (horizontal or down sloping and persisting for at least 0.08 seconds after J-point, on at least three consecutive complexes) between 2.5 and 12 minutes of initiation with modified Bruce treadmill ergometer protocol. If the ETT is interrupted before reaching positivity for any reason, the patient will not be included.
    - Stability criteria: Difference between selection (Day -7) and inclusion (Day 0) ETT measurements has to be within 20% of the Day 0 value.
    2. At least 4 anginal attacks in the 4 week period preceding randomisation
    3. Compliance to treatment during the run-in period, i.e. placebo on top of background treatment (calculated compliance at least 85%, in addition, patient should not have missed more than one full daily dose).
    E.4Principal exclusion criteria
    1. Incapacidad para comprender el lenguaje en el que se explica la información para el paciente;
    2. Presencia o historia de consumo de drogas o abuso de alcohol;
    3. Presencia de enfermedad maligna en los 5 años anteriores;
    4. La paciente es una mujer en edad fértil que no usa un método anticonceptivo fiable; (Nota: un método de control de natalidad de alta eficacia se define como aquel que tiene una frecuencia baja de fracasos (esto es, menos del 1% por año) cuando se usa sistemática y correctamente, como los implantes, inyectables, anticonceptivos orales combinados, algunos DIU, abstinencia sexual o vasectomía de la pareja);
    5. La paciente es una mujer embarazada o en período de lactancia;
    6. Participación en un ensayo clínico simultáneo o en otro ensayo en las 4 semanas anteriores;
    7. Participación repetida en este ensayo;
    8. Previsión de mal cumplimiento con la medicación;
    9. El paciente es el propio investigador.
    Criterios de exclusión específicos del ensayo:
    1. Infarto agudo de miocardio reciente, cirugía de bypass coronario menos de 3 meses antes de la inclusión o angioplastia coronaria menos de 6 meses antes de la inclusión;
    2. Angina inestable, angina de Prinzmetal o angina microvascular;
    3. Síntomas de angina de pecho típicamente inducidos por factores distintos del ejercicio físico;
    4. Enfermedad conocida de alto grado en arterias coronarias principales izquierdas que no se ha corregido por bypass quirúrgico ni mejorado mecánicamente;
    5. Antecedentes de insuficiencia mitral de importancia clínica no tratada, pericarditis constrictiva, taponamiento pericárdico, hipertensión pulmonar severa, estenosis aórtica, cardiomiopatía hipertrófica obstructiva u otras causas de obstrucción del tracto de salida del ventrículo izquierdo. Si tales trastornos son tratados, el tratamiento deberá ser confirmado por ecocardiograma no anterior a 6 meses. La importancia clínica de los trastornos se deja al juicio del investigador;
    6. Hipersensibilidad o contraindicaciones para nitrovasodilatadores, especialmente PETN y nitroglicerina;
    7. Angioplastia coronaria transluminal percutánea (ACTP) optativa prevista en las 12 semanas siguientes;
    8. Pacientes que no puedan realizar pruebas de ejercicio, en particular por motivos musculares, articulares y/o del esqueleto;
    9. Cardiopatía de importancia clínica distinta de la arteriopatía coronaria;
    10. Insuficiencia cardíaca congestiva estadio III o IV según la asociación de cardiología de Nueva York (NYHA)
    11. Hipotensión sintomática (< 100 mmHg, vértigo, disregulación ortostática);
    12. Hipertensión no controlada (presión arterial sistólica en reposo por encima de 180 mmHg o presión arterial diastólica en reposo por encima de 100 mmHg);
    13. Fibrilación auricular, flúter, implantación de marcapasos o desfibrilador cardioverter;
    14. Anomalías en el ECG que podrían hacer confusa la interpretación de la PTE;
    15. Alteración de la repolarización observada en el ECG basal;
    16. Trastornos hepáticos (alanina aminotransferasa [ALT] más de 3 veces por encima del valor normal), insuficiencia renal (nivel sérico de creatinina por encima de 180 µmol/l);
    17. Trastornos electrolíticos;
    18. Anemia (hemoglobina por debajo de 10,0 mg/dl);
    19. Trastornos del tiroides (excepto si es estable y controlado por tratamiento con tiroxina desde 3 meses antes como mínimo);
    20. Cualquier tratamiento con medicación concomitante no autorizada que no se pueda interrumpir mientras dure el ensayo;
    21. Tratamiento con amiodarona en los 3 meses anteriores a la selección;
    22. Uso de bepridil < 7días antes de la selección;
    23. Uso de digital/glucósidos cardíacos 6 meses antes de la selección;
    24. Incapacidad o ausencia de consentimiento para eliminar nitratos de acción prolongada, bloqueadores del canal del calcio, trapidil, molsidomina, ranolazina, trimetazidina, nicorandil;
    25. Tratamiento con sildenafil (Viagra®) u otros inhibidores de la fosfodiesterasa-5 durante la participación en el ensayo;
    26. Enfermedad grave con probabilidad de interferir con el ensayo según el criterio del investigador;
    27. Portador conocido de antígeno de hepatitis B (HBs), virus de la inmunodeficiencia humana (VIH) o anticuerpos para virus de hepatitis C (VHC);
    28. Antecedentes de trastornos siquiátricos o del comportamiento graves que pudieran interferir con el ensayo;
    29. Antecedentes de reacción medicamentosa anormal grave;
    30. Uso del medicamento en investigación en los 30 días previos a la selección, o tratamiento simultáneo con uno o más medicamentos en investigación.
    E.5 End points
    E.5.1Primary end point(s)
    De eficacia primario:
    Cambio en la duración total del ejercicio (DTE, [segundos]) con respecto al valor basal después de 12 semanas de tratamiento con 80 mg de PETN bid en comparación con placebo bid evaluado en el nivel mínimo en plasma entre la dosis de la mañana y la del mediodía (es decir, 5 horas después de la toma de la dosis de la mañana de la medicación del estudio).
    De eficacia secundario:
    - Frecuencia, intensidad y duración de los ataques de angina (según el diario del paciente);
    - Cambio en el tiempo transcurrido hasta el inicio del dolor anginoso en la prueba de tolerancia al ejercicio (PTE) después de 6 y 12 semanas de tratamiento;
    - Cambio en la capacidad de ejercicio (equivalentes metabólicos [MET]) después de 6 y 12 semanas de tratamiento;
    - Utilización concomitante de nitratos de acción corta (según el diario del paciente);
    - Cambio en el tiempo transcurrido hasta la limitación por angina (TLA, segundos) durante la PTE después de 6 y 12 semanas de tratamiento;
    - Cambio en la DTE (segundos) durante la PTE después de 6 semanas de tratamiento;
    - Cambio en el tiempo transcurrido hasta la depresión de 1 mm en el segmento ST (TST) (horizontal o en pendiente descendente durante más de 0,08 s después del punto J) después de 6 y 12 semanas de tratamiento;
    - Intensidad y duración de los ataques de angina (según el diario del paciente);
    - Cambio en las puntuaciones de calidad de vida relativa a la salud después de 12 semanas de tratamiento;
    - Escala de Borg.

    Primary efficacy:
    Change in Total Exercise Duration (TED) [seconds]) from baseline after 12 weeks of treatment with PETN 80 mg bid as compared to placebo bid assessed in the trough between the morning and the midday dose, (i.e. at 5 h after intake of morning dose of study medication).
    Secondary efficacy:
    - Angina attack frequency, intensity, and duration (according to patient diary);
    - Change in time to onset of anginal pain on ETT after 6 and 12 weeks of treatment;
    - Change in exercise capacity (METs) after 6 and 12 weeks of treatment
    - Concomitant use of short-acting nitrates (according to patient diary)
    - Change in time to limiting angina (TLA, seconds) during ETT after 6 and 12 weeks of treatment
    - Change in TED (seconds) during ETT after 6 weeks of treatment
    - Change in time to 1 mm ST segment depression (TST) (horizontal or down-sloping for more than 0.08 s after the J point) after 6 and 12 weeks of treatment;
    - Angina attack intensity, and duration (according to patient diary);
    - Change in Health related quality of life scores after 12 weeks of treatment;
    - Borg scale.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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
    Última visita del último paciente (fecha estimada en marzo).
    Last visit of last subject, estimated March 2012.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 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 Yes
    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 2010-11-25. Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 528
    F.4.2.2In the whole clinical trial 778
    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)
    Subjects will return to their normal standard of care after participation in the clinical trial.
    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 Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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