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    Summary
    EudraCT Number:2011-004995-13
    Sponsor's Protocol Code Number:38372
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004995-13
    A.3Full title of the trial
    Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric study
    Endovasculaire renale sympathicusdenervatue versus spironolacton bij therapie-resistente hypertensie: een gerandomiseerde, multicentrische studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Denervation of the nerves to the kidney versus medical treatment in patients with refractory hypertension
    Denervatie van de zenuwen naar de nieren versus medicamenteuze behandeling voor patiënten met moeilijk behandelbare hypertensie
    A.3.2Name or abbreviated title of the trial where available
    RRSS
    RRSS
    A.4.1Sponsor's protocol code number38372
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointA.H. van den Meiracker
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107034220
    B.5.5Fax number00310107034937
    B.5.6E-maila.vandenmeiracker@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 spironolactone
    D.2.1.1.2Name of the Marketing Authorisation holderNetherlands
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namespironolactone
    D.3.4Pharmaceutical form 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 INNSpironolacton
    D.3.9.1CAS number 52-01-7
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameSPIRONOLACTONE
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    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
    Hypertension
    hypertensie
    E.1.1.1Medical condition in easily understood language
    high blood pressure
    hoge bloeddruk
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular 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 compare the effect of renal sympathetic denervation with the spironolactone in treatment-resistant hypertension on blood pressure
    Vergelijking van renale sympathische denervatie met spironolacton op de bloeddruk bij therapie-resistente hypertensie
    E.2.2Secondary objectives of the trial
    - Proportion of patients per intervention group with normalization of their 24-hour ambulatory blood pressure
    - Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of ≥ 10 mmHg systolic and ≥ 5 mmHg diastolic.
    - Cost effective of RFSD
    - Difference in scores of quality of llife between RFSD and spironolactone group
    - Predictive value of clonidine-suppressiontest for the blood pressure response to RFSD
    - Percentage patiënten per interventiegroep met normalisatie van de 24-uurs ambulante bloeddruk.
    - Percentage patiënten per interventiegroep met 24-uurs bloeddrukdaling van ≥10 mmHg systolisch en ≥ 5 mmHg diastolisch.
    - Kosteneffectiviteit van RFSD.
    - Verschil in kwaliteit van leven score tussen RFSD en spironolacton groep.
    - Voorspellende waarde van de clonidinesuppressietest op de bloeddrukdaling door RFSD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 18 and 75 yrs
    Treatment-reistant hypertension
    Willingness to give written informed consent
    Leeftijd tussen 18 en 75
    Therapie-resistente hypertensie
    Bereidheid tot het geven van schriftelijke toestemming
    E.4Principal exclusion criteria
    Secondary forms of hypertension
    Renal arteries not accessible to intervention
    Suboptimal dosing of anthypertensive medication
    White coat hypertension
    Pregnancy
    Renal insufficiency (GFR < 45 ml/min
    Secundaire vormen van hypertensie
    Nierarterie of nierarteriën ontoegangelijk voor interventie
    Suboptimale dosering antihypertensiva
    Wittejashypertensie
    Zwangerschap
    Nierinsufficientie (GFR < 45 ml/min)
    E.5 End points
    E.5.1Primary end point(s)
    Difference in 24-hour ambulatory blood pressure decrease between the RFSD and spironolactone group.
    Verschil in 24-uurs ambulante bloeddrukdaling tussen de RFSD en spironolacton groep.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    Op 6 maanden
    E.5.2Secondary end point(s)
    - Proportion of patients per intervention group with normalization of their 24-hour ambulatory blood pressure
    - Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of ≥ 10 mmHg systolic and ≥ 5 mmHg diastolic.
    - Cost effective of RFSD
    - Difference in scores of quality of llife between RFSD and spironolactone group
    - Predictive value of clonidine-suppressiontest for the blood pressure response to RFSD
    - Percentage patiënten per interventiegroep met normalisatie van de 24-uurs ambulante bloeddruk.
    - Percentage patiënten per interventiegroep met 24-uurs bloeddrukdaling van ≥10 mmHg systolisch en ≥ 5 mmHg diastolisch.
    - Kosteneffectiviteit van RFSD.
    - Verschil in kwaliteit van leven score tussen RFSD en spironolacton groep.
    - Voorspellende waarde van de clonidinesuppressietest op de bloeddrukdaling door RFSD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 months
    Op 6 maanden
    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 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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    renale sympathische denervatie
    renal sympathetic denervation
    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 concerned7
    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
    6 months of follow up after intervention, unless death or other serious adverse effect not allowing to continue the trial
    6 maanden follow-up na interventie, tenzij overlijden of een andere serieuze bijwerking waardoor continuering van de trial onmogelijk is.
    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 months6
    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 months6
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state130
    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)
    care according to medical standard in the Netherlands
    behandeling overeenkomstig de medische standaard in Nederland
    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 Decision2011-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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