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    Summary
    EudraCT Number:2015-000645-23
    Sponsor's Protocol Code Number:Borealis1
    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:2015-03-27
    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 number2015-000645-23
    A.3Full title of the trial
    Safety, tolerability and efficacy of nocturnal hypertension treatment with domperidone in the sleep apnea-hypopnea syndrome. Pilot study.
    Seguridad, tolerabilidad y eficacia del tratamiento de la hipertensión arterial nocturna con domperidona en el síndrome de apneas-hipoapneas durante el sueño. Estudio piloto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability and efficacy of hypertension treatment with domperidone patients with sleep apnea.
    Seguridad, tolerabilidad y eficacia del tratamiento de la hipertensión arterial con domperidona en pacientes con apnea del sueño.
    A.4.1Sponsor's protocol code numberBorealis1
    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 SponsorCIBER (Centro de Investigacion Biomedica en Red)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Sanidad, Servicios Sociales e Igualdad (Instituto Carlos III)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street Addressc/ Azcona,31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-maill.plasencia@dynasolutions.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 Motilium
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Dr. Esteve, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form 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 INNDOMPERIDONE
    D.3.9.1CAS number 57808-66-9
    D.3.9.4EV Substance CodeSUB06361MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nocturnal hypertension in the sleep apnea-hypopnea syndrome.
    Hipertensión arterial nocturna en el síndrome de apneas-hipoapneas durante el sueño.
    E.1.1.1Medical condition in easily understood language
    Nocturnal hypertension in patients with sleep apnea syndrome.
    Hipertensión arterial en pacientes con apnea del sueño.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10040976
    E.1.2Term Sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10019180
    E.1.2Term HBP
    E.1.2System Organ Class 100000004866
    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 safety and tolerability of treatment with domperidone and to analyze pressure values after administration of domperidone in male patients with sleep apnea-hypopnea syndrome during sleep (SAHS) and nocturnal hypertension.
    Evaluar la seguridad y la tolerabilidad del tratamiento con domperidona y analizar los valores tensionales tras la administración de domperidona en pacientes de sexo masculino con síndrome de apneas-hipoapneas durante el sueño (SAHS) e hipertensión arterial nocturna.
    E.2.2Secondary objectives of the trial
    To analyze possible changes in quality of life for male patients with SAHS and nocturnal hypertension evaluating possible differences in clinical questionnaires before and after administration of domperidone.
    Analizar posibles cambios en calidad de vida de los pacientes de sexo masculino con SAHS e hipertensión arterial nocturna evaluando posibles diferencias en cuestionarios clínicos antes y después de la administración de domperidona.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Men aged between 18 and 65 years old.
    b) Apnea hypopnea index (AHI) during sleep greater than 30.
    c) Nocturnal hypertension (Mean nocturnal systolic blood pressure equal or greater than 120 mmHg).
    d) Signature of informed consent to participate in the study.
    a) Varones de edad comprendida entre 18 y 65 años de edad.
    b) Índice de apneas hipopneas (IAH) durante el sueño mayor de 30.
    c) Hipertensión arterial nocturna (Presión arterial sistólica media nocturna igual o mayor de 120 mmHg).
    d) Firma del consentimiento informado para participar en el estudio.
    E.4Principal exclusion criteria
    a) Obesity (BMI> 35).
    b) Previous treatment with CPAP (Continuous Positive Airway Pressure).
    c) Disabling daytime sleepiness or difficulting patient activity.
    d) Notorious cardiovascular, renal, hepatic or hematologic comorbidities at the discretion of the investigator would interfere with the study results.
    e) Antihypertensive drugs intake.
    f) Any contraindication to domperidone (allergy compound, prolactinoma, gastrointestinal hemorrhage, mechanical obstruction, perforation, mesenteric ischemia) (see ANNEX I: Overview of the drug).
    g) Intake of anticholinergic drugs, ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QT interval.
    h) Written informed consent not obtained.
    a) Obesidad (IMC > 35).
    b) Tratamiento previo con CPAP.
    c) Somnolencia diurna invalidante o que dificulte la actividad del paciente.
    d) Comorbilidades cardiovasculares, renales, hepáticas o hematológicas notorias que a criterio del investigador puedan interferir con los resultados del estudio.
    e) Toma de fármacos antihipertensivos.
    f) Cualquier contraindicación a la domperidona (alergia al compuesto, prolactinoma, hemorragia digestiva, obstrucción mecánica, perforación, isquemia mesentérica) (ver ANEXO I: Ficha técnica del fármaco).
    g) Toma de fármacos anticolinérgicos, ketoconazol, eritromicina u otros inhibidores potentes del CYP3A4 que prolonguen el intervalo QT.
    h) La no firma del consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events related to study medication, and changes in nocturnal blood pressure (BP): SBP and DBP by ambulatory monitoring of blood pressure..
    Incidencia de reacciones adversas relacionadas con la medicación en estudio, en una nueva indicación.
    Cambios de presión arterial (PA): PAS y PAD nocturnas mediante MAPA (Monitorización Ambulatoria de la Presión Arterial).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse reactions will be evaluated along the study (12 weeks).
    Ambulatory monitoring of blood pressure will be evaluated at the Screening, Week 6 and Week 12.
    Las reacciones adversas serán evaluadas a lo largo del estudio (12 semanas).
    La monitorización de la presión arterial se realizará en la Visita de Selección, Semana 6 y Semana 12.
    E.5.2Secondary end point(s)
    Changes in Epworth Sleepiness Scale and Quebec questionnaire.
    Changes in the quality of life of patients using EuroQoL-5D.
    Cambios en la Escala de somnolencia de Epworth y cuestionario Quebec.
    Cambios en la calidad de vida de los pacientes mediante EuroQol-5D.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 and Week 12.
    Día 0 y Semana 12.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    UVUP (Última Visita Último Paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    Expected normal treatment.
    Tratamiento clínico habitual.
    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 Decision2015-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-06-02
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