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    Summary
    EudraCT Number:2012-003514-14
    Sponsor's Protocol Code Number:HYPODD01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003514-14
    A.3Full title of the trial
    HYPOVITAMINOSIS D AND ORGAN DAMAGE IN PATIENTS WITH HYPERTENSION: EFFECTS OF SUPPLEMENTATION WITH CHOLECALCIFEROL
    IPOVITAMINOSI D E DANNO D'ORGANO IN PAZIENTI CON IPERTENSIONE ARTERIOSA: EFFETTI DELLA SUPPLEMENTAZIONE CON COLECALCIFEROLO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TO DETERMINE IF PHARMACOLOGICAL TREATMENT OF LOW VITAMIN D CONCENTRATION MAY REDUCE HEART, RENAL AND VASCULAR DAMAGE IN PATIENTS WITH HIGH BLOOD PRESSURE LEVELS
    VALUTARE SE LA CORREZIONE FARMACOLOGICA DELLE SCARSE RISERVE DI VITAMINA D POSSA RIDURRE L’INSORGENZA DI DANNI A CUORE, RENI E VASI SANGUIGNI IN PAZIENTI CON ELEVATI LIVELLI DI PRESSIONE ARTERIOSA
    A.3.2Name or abbreviated title of the trial where available
    HYPODD
    HYPODD
    A.4.1Sponsor's protocol code numberHYPODD01
    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 SponsorUNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II
    B.1.3.4CountryItaly
    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 supportFondazione SIIA - Società Italiana dell’Ipertensione Arteriosa
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportABIOGEN s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi di Napoli ''Federico II''
    B.5.2Functional name of contact pointDipartimento di Medicina Clinica e
    B.5.3 Address:
    B.5.3.1Street AddressVia S. Pansini, 5
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0817463686
    B.5.5Fax number0815466152
    B.5.6E-mailstrazzul@unina.it
    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 DIBASE*OS SOLUZ 2,5ML 25000UI
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Oral solution
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeVITAMINA D
    D.3.9.4EV Substance CodePRD386130
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.625
    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 placeboOral solution
    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
    HYPERTENSION AND HYPOVITAMINOSIS D
    IPERTENSIONE ARTERIOSA ED IPOVITAMINOSI D
    E.1.1.1Medical condition in easily understood language
    HIGH BLOOD PRESSURE LEVELS AND LOW VITAMIN D LEVELS
    ELEVATI VALORI DI PRESSIONE ARTERIOSA E BASSI LIVELLI DI VITAMINA D
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10015488
    E.1.2Term Essential hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10047626
    E.1.2Term Vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 of cholecalciferol supplementation on blood pressure control and clinical and subclinical organ damage in patients with essential hypertension, stable drug therapy, and documented vitamin D deficiency
    Valutare l’efficacia della supplementazione con colecalciferolo sul controllo pressorio e sulla progressione del danno d’organo subclinico e clinico in pazienti con ipertensione arteriosa essenziale, trattamento farmacologico stabile e documentato deficit di vitamina D
    E.2.2Secondary objectives of the trial
    To evaluate the influence of vitamin D receptor (VDR) allelic variants on pharmacological response to oral cholecalciferol therapy
    Valutare l'influenza delle varianti alleliche del recettore della vitamina D (VDR) sulla risposta farmacologica alla supplementazione per os con colecalciferolo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:01
    Date:2012/07/25
    Title:Pharmacogenomic of cholecalciferol supplementation
    Objectives:To evaluate the effects of vitamin D receptor allelic variants on response to cholecalciferol supplementation in patients with hypovitaminosis D
    FARMACOGENOMICA:
    Vers:01
    Data:2012/07/25
    Titolo:Farmacogenomica della supplementazione con colecalciferolo
    Obiettivi:Valutare gli effetti che le varianti alleliche del gene del recettore della vitamina D (VDR) possono avere sulla risposta farmacologica alla supplementazione con colecalciferolo nei soggetti con ipovitaminosi D
    E.3Principal inclusion criteria
    Patients of both sexes with essential hypertension, systolic and diastolic blood pressure lower than 140 mmHg and 90 mmHg respectively during stable drug's treatment, and serum levels of 25OHD3 lower than 20 ng/ml
    Pazienti ambosessi con ipertensione arteriosa essenziale, valori di pressione arteriosa sistolica e diastolica stabilmente inferiori a 140 mmHg e 90 mmHg in corso di terapia farmacologica e livelli serici di 25OHD3 inferiori a 20 ng/ml
    E.4Principal exclusion criteria
    - Age <35 yrs. or >75 yrs. - Body Mass Index <20 Kg/m2 or >35 Kg/m2 - Secondary hypertension - Personal and/or family history of rickets and osteomalacia - Serum levels of total calcium and/or intact PTH beyond the upper limit of laboratory reference range - Primary or secondary hyperparathiroidism - Fasting blood glucose >126 mg/dL. - Glomerular filtrate ratio <60 ml/min/1,73 m2 - Renal tubular acidosis - TSH serum levels <0.5 mUI/ml or >4.5 mUI/ml - Alteration in nutritional status - Personal history positive for sarcoidosis, type I and II diabetes mellitus, nephrolithiasis, atrial fibrillation, atrial flutter, atrial or ventricular extrasystoles Lown class II or higher. - Electrocardiographic evidence of non-normal sinus rhythm or atrial/ventricular extrasystoles. - Positive history for assumption of antiarrhythmic agents, digoxin, warfarin, anticonvulsant or barbituric drugs, systemic glucocorticoids, antacid drugs containing aluminum, magnesium, cholestiramine or colestipol, orlistat, rifampicin, antiresorptive drugs, vitamin D.
    - Età &lt;35 anni e &gt;75 anni - Indice di massa corporea &lt;20 Kg/m2 e &gt;35 Kg/m2 - Forme secondarie di ipertensione arteriosa - Anamnesi personale e familiare positiva per rachitismo e osteomalacia - Livelli serici di calcemia serica totale e/o PTH intatto superiori al limite massimo di riferimento - Ipoparatiroidismo primitivo o secondario - Glicemia a digiuno &gt;126 mg/dL - Filtrato glomerulare stimato &lt;60 ml/min/1,73 m2 - Acidosi tubulare renale - Livelli serici di TSH &lt;0.5 mUI/ml o &gt;4.5 mUI/ml - Alterazione dello stato nutrizionale ed assorbitivo - Anamnesi personale positiva per sarcoidosi, diabete mellito di tipo I e II, nefrolitiasi, fibrillazione atriale, flutter atriale, extrasistolia atriale o ventricolare di classe Lown II o superiore. - Evidenza elettrocardiografica di ritmo cardiaco differente dal ritmo sinusale o extrasistolia atriale/ventricolare - Anamnesi farmacologia positiva per l’assunzione di farmaci antiaritmici, digossina e/o digitale, warfarin, anticonvulsivanti o barbiturici, glucocorticoidi sistemici, antiacidi contenenti alluminio, integratori contenenti magnesio, colestiramina o colestipolo, orlistat, rifampicina, antiriassorbitivi e/o vitamina D.
    E.5 End points
    E.5.1Primary end point(s)
    - Comparative evaluation between the two groups of overall drugs consumption for maintenance of blood pressure control during the study - A composite endopoint linked to the evaluation of organ damage(considered reached after achieving at least one secondary endpoint)
    - Valutazione comparativa tra i due gruppi del consumo globale di farmaci necessario per il mantenimento del controllo pressorio nel corso dello studio - Un endpoint composito collegato alla valutazione della progressione del danno d’organo nei due gruppi di studio (ritenuto raggiunto in caso di raggiungimento di almeno un endpoint secondario)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve-months
    Dodici mesi
    E.5.2Secondary end point(s)
    - Left ventricular massreduction ≥7 g/m2.7 - Pulse wave velocity reduction ≥ 0.9 m/s - Albuminuria reduction ≥ 45 mg/24h - Reduction in circulating levels of atrial natriuretic peptide ≥600 fmol/ml
    - Riduzione della massa ventricolare sinistra ≥7 g/m2.7 - Riduzione della velocità dell’onda di polso ≥0.9 m/s - Riduzione dell’albuminuria ≥45 mg/24h - Riduzione dei livelli circolanti di peptide natriuretico atriale ≥600 fmol/ml
    E.5.2.1Timepoint(s) of evaluation of this end point
    Twelve months
    Dodici mesi
    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 No
    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 Yes
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2013-01-11. 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 state200
    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, all patients will be followed by single centers recruiters, all third-level centers for the hypertension study and treatment
    Al termine dello studio i pazienti continueranno ad essere seguiti dai singoli centri reclutatori, tutti di terzo livello per lo studio ed il trattamento dell’ipertensione arteriosa
    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 Decision2013-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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