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    Summary
    EudraCT Number:2014-000605-12
    Sponsor's Protocol Code Number:notapplicable1
    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:2014-03-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000605-12
    A.3Full title of the trial
    Thiazide diuretics versus calcium channel blockers for the treatment of calcineurin inhibitor-induced hypertension in patients with psoriasis or eczema: a single-center randomized cross-over trial.
    Thiazide diuretica versus calcium antagonisten voor de behandeling van calcineurine remmer-geïnduceerde hypertensie bij patiënten met psoriasis of eczeem: een single-center randomized cross-over trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two drugs against high blood pressure in dermatology patients.
    Vergelijking van twee medicijnen tegen hoge bloeddruk bij dermatologie patiënten.
    A.3.2Name or abbreviated title of the trial where available
    TT-study dermatology
    TT-studie dermatologie
    A.4.1Sponsor's protocol code numbernotapplicable1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Amlodipine
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    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 Amlodipine
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 3
    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 Chlortalidone
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm Nederland bv
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 4
    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 Chlortalidone
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm Nederland bv
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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, induced by the use of a Calcineurin Inhibitor (CNI)
    Hypertensie, geïnduceerd door het gebruik van een Calcineurine Remmer (CNI)
    E.1.1.1Medical condition in easily understood language
    Hypertension, high blood pressure
    Hypertensie, hoge bloeddruk
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 blood pressure lowering effect of thiazides against calcium channel blockers in eczema or psoriasis patients with CNI-induced hypertension .
    Om de bloeddrukverlagende effecten te vergelijken van thiazide diuretica tegenover calcium kanaal blokkers bij patiënten met psoriasis of eczeem met CNI-geïnduceerde hypertensie.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Treatment with tacrolimus or cyclosporine
    • MDRD-GFR ≥ 30 ml/min
    • Systolic blood pressure > 140 mmHg but < 180 mmHg during 24-hours blood pressure measurement
    • Stable background antihypertensive drugs (i.e., no anticipated change in dose during the study period)
    • 18 years or older
    • Behandeling met tacrolimus of cyclosporine
    • MDRD-GFR ≥ 30 ml/min
    • Systolische bloeddruk > 140 mmHg, maar < 180 mmHg tijdens 24-uurs bloeddrukmeting
    • Stabiele achtergronds antihypertensiva (geen geanticipeerde dosisaanpassingen tijdens de studieperiode)
    • 18 jaar of ouder
    E.4Principal exclusion criteria
    • MDRD-GFR < 30 ml/min
    • Serum sodium < 136 mmol/l
    • Serum potassium < 3.5 mmol/l
    • Proteinuria > 1.0 g/10 mmol creatinine
    • Systolic blood pressure < 140 mmHg during 24-hour blood pressure measurement
    • Systolic blood pressure > 180 mmHg during 24-hour blood pressure measurement
    • The use of co-trimoxazol or prednisone
    • Incapacitated subjects
    • Pregnancy
    • Use of a thiazide diuretic in combination with a calcium channel blocker
    • Use of loop diuretics
    • MDRD-GFR < 30 ml/min
    • Serum natrium < 136 mmol/l
    • Serum kalium < 3.5 mmol/l
    • Proteïnurie > 1.0 g/10 mmol kreatinine
    • Systolische bloeddruk < 140 mmHg tijdens 24-uurs bloeddrukmeting
    • Gebruik van co-trimoxazol of prednison
    • Patienten met een mentale beperking
    • Zwangerschap
    • Systolische bloeddruk > 180 mmHg tijdens 24-uurs bloeddrukmeting
    • Gelijktijdig gebruik van thiazide diureticum in combinatie met een calcium kanaal blokker
    • Gebruik van lisdiuretica
    E.5 End points
    E.5.1Primary end point(s)
    Change of average 24-hour systolic blood pressure during eight weeks of treatment.
    Daling van de gemiddelde 24-uurs systolische bloeddruk tijdens 8 weken behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 8 and 18 weeks.
    Na 8 en 18 weken.
    E.5.2Secondary end point(s)
    • Incidence of hyperkalemia (serum potassium > 5.0 mmol/l)
    • Incidence of non-anion gap metabolic acidosis (serum bicarbonate < 20 mmol/l)
    • Incidence of edema (as assessed by physical examination)
    • Number of antihypertensive drugs
    • Side-effects:
    - Decrease in MDRD-GFR
    - Development of hyponatremia
    - Development of hypomagnesemia
    - Development of hypokalemia
    - Increase in HbA1c
    - Fluctuation in plasma tacrolimus level
    - Occurrence of gout
    Incidentie van hyperkaliëmie (serum kalium > 5,0 mmol/l);
    • Incidentie van een non-anion gap metabole acidose (serum bicarbonaat < 20 mmol/l);
    • Incidentie van oedeem (beoordeeld door middel van lichamelijk
    onderzoek);
    • Aantal antihypertensiva;
    • Bijwerkingen:
    - eGFR dalingen;
    - Ontwikkeling van hyponatriëmie;
    - Ontwikkeling van hypomagnesiëmie;
    - Ontwikkeling van hypokaliëmie;
    - Stijging van HbA1c;
    - Fluctuerende tacrolimus spiegel;
    - Voorkomen van jicht.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 8 and 18 weeks.
    Na 8 en 18 weken.
    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 No
    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) 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 No
    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) Yes
    E.8.2.2Placebo No
    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
    Laatste bezoek van de laatste patiënt.
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 2014-03-11. 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 state15
    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)
    It is possible to continue treatment with chlortalidone or amlodipine if the effects is superior to the use of the other drug.
    Het is mogelijk om behandeling met chloortalidon of amlodipine te continueren na het beëindigen van de studie als blijkt dat de effecten superieur zijn aan die van het andere middel.
    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 Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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