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    Summary
    EudraCT Number:2013-004460-66
    Sponsor's Protocol Code Number:KARAASS-1
    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:2014-03-06
    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 number2013-004460-66
    A.3Full title of the trial
    Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system
    Peroralt kaliumtilskud i raske mænd – interaktioner med renin-angiotensin-aldosteron systemet og det sympatiske nervesystem

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system
    Peroralt kaliumtilskud i raske mænd – interaktioner med renin-angiotensin-aldosteron systemet og det sympatiske nervesystem
    A.4.1Sponsor's protocol code numberKARAASS-1
    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 SponsorJørgen Jeppesen
    B.1.3.4CountryDenmark
    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 supportGlostrup Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRasmus Dreier
    B.5.2Functional name of contact pointRasmus Dreier
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringvej 57
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.6E-mailrasmus.dreier.01@regionh.dk
    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 Kaleorid, 750mg
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma 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.3.4Pharmaceutical form Prolonged-release 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 INNPotassium chloride
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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 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
    Blood pressure regulation and hypertension
    Regulation af blodtryk og forhøjet blodtryk
    E.1.1.1Medical condition in easily understood language
    Blood pressure regulation and hypertension
    Regulation af blodtryk og forhøjet blodtryk
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10008393
    E.1.2Term Change in blood pressure
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10053967
    E.1.2Term Potassium supplementation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to test whether oral potassium supplementation, administered as Kaleorid, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system.
    Forsøgets formål er at afklare hvorledes et kaliumtilskud til kosten, i form af lægemidlet Kaleorid, påvirker reguleringen af blodtrykket hos mennesker. Mere specifikt er formålet at undersøge hvorledes et kosttilskud med kalium påvirker:

    • Renin-angiotensin-aldosteron systemet
    samt:
    • Det sympatiske nervesystem

    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male
    Age: 20-55
    Office Blood pressure: < 140/90 mmHg
    BMI: 18,5-30,0 kg/m2
    Signed consent form
    Hankøn
    Alder: 20-55 år
    Konsultationsblodtryk: < 140/90 mmHg
    BMI: 18,5-30,0 kg/m2
    Signeret samtykkeerklæring
    E.4Principal exclusion criteria
    Diabetes mellitus
    Cerebrovascular disease, ischemic heart disease, peripheral artery disease
    Kidney disease
    Adrenal disease
    Ulcers
    Medical treatment
    Drug or alcohol abuse
    Pathological ECG
    Mental not suitable
    Hyperkalemia
    Diabetes Mellitus
    Cerebrovaskulær lidelse, iskæmisk hjertesygdom, perifer arteriesygdom
    Nyresygdom
    Binyresygdom
    Mavesår
    Aktiv medicinsk behandling
    Stof eller alkohol misbrug
    Patologisk EKG
    Psykisk fremtrædende modstridende med gennemførelse af forsøget
    Hyperkaliæmi
    E.5 End points
    E.5.1Primary end point(s)
    Angiotensin II stimulated S-aldosterone
    Angiotensin II stimuleret S-aldosteron
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date: 2017-10-01
    Dato: 2017-10-01
    E.5.2Secondary end point(s)
    Angiotensin II stimulated blood pressure
    Angiotensin II stimulated total peripheral resistance (TPR)
    Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen
    Level of receptor expression and receptor function in resistance vessels from fat biopsies

    P-epinephrine and P-norepinephrine
    Urinary content of epinephrine and norepinephrine
    Angiotensin II stimulated P-epinephrine and Angiotensin II stimulated P-norepinephrine
    Angiotensin II stimuleret blodtryk
    Angiotensin II stimuleret total perifer modstand (TPR)
    Angiotensin II stimuleret modstandsindex (RI) i a. renalis, truncus coeliacus og a. mesenterica superior
    Niveau af receptorekspression og receptorfunktion i modstandskar fra fedtbiopsier

    P-epinephrine og P-norepinephrine
    Urinindhold af epinephrine og norepinephrine
    Angiotensin II stimuleret P-epinephrine og Angiotensin II stimuleret P-norepinephrine
    E.5.2.1Timepoint(s) of evaluation of this end point
    Date: 2017-10-01
    Dato: 2017-10-01
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    To evaluate human physiology.
    At undersøge human fysiologi.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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 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
    Sidste besøg sidste deltager.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 25
    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 Yes
    F.3.2Patients No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 25
    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)
    None
    Ingen
    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 Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-21
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