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    Summary
    EudraCT Number:2011-004249-42
    Sponsor's Protocol Code Number:Sevicontrol-2
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004249-42
    A.3Full title of the trial
    SEVICONTROL-2:
    Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial
    SEVICONTROL-2:
    Wirksamkeit und Sicherheit einer sequenziellen Umstellung von Patienten mit unzureichend kontrollierter moderater essentieller Hypertonie unter einer Monotherapie mit Candesartan 32 mg auf die Fixkombination Olmesartan 40 mg/Amlodipin 10 mg – eine offene Phase IV - Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SEVICONTROL-2:
    Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial
    SEVICONTROL-2:
    Wirksamkeit und Sicherheit einer sequenziellen Umstellung von Patienten mit unzureichend kontrollierter moderater essentieller Hypertonie unter einer Monotherapie mit Candesartan 32 mg auf die Fixkombination Olmesartan 40 mg/Amlodipin 10 mg – eine offene Phase IV - Studie
    A.3.2Name or abbreviated title of the trial where available
    Sevicontrol-2
    Sevicontrol-2
    A.4.1Sponsor's protocol code numberSevicontrol-2
    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 SponsorIPPMed GmbH
    B.1.3.4CountryGermany
    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 supportDaiichi Sankyo Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIPPMed GmbH
    B.5.2Functional name of contact pointIPPMed
    B.5.3 Address:
    B.5.3.1Street AddressMenzelstraße 21
    B.5.3.2Town/ cityMahlow
    B.5.3.3Post code15831
    B.5.3.4CountryGermany
    B.5.4Telephone number+49033793148790
    B.5.5Fax number+49033793148792
    B.5.6E-mailpeter.bramlage@ippmed.de
    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 Atacand 16 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca Deutschland 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANDESARTAN
    D.3.9.1CAS number 139481-59-7
    D.3.9.4EV Substance CodeSUB06070MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 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 Atacand protect
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca Deutschland 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANDESARTAN
    D.3.9.1CAS number 139481-59-7
    D.3.9.4EV Substance CodeSUB06070MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 Olmetec
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Deutschland 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 Film-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.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Sevikar 40/5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo GmbH Deutschland
    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 Film-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.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMLODIPINE
    D.3.9.1CAS number 88150-42-9
    D.3.9.4EV Substance CodeSUB05467MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 5
    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 Sevikar 40/10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo GmbH Deutschland
    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 Film-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.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMLODIPINE
    D.3.9.1CAS number 88150-42-9
    D.3.9.4EV Substance CodeSUB05467MIG
    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
    moderate hypertension
    mittelschwere Hypertonie
    E.1.1.1Medical condition in easily understood language
    moderately elevated blood pressure
    mittelschwerer Bluthochdruck
    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
    Efficacy in blood significantly improved blood pressure reduction after six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg as compared to monotherapy with 32 mg candesartan and safety of sequential therapy change via 6 weeks monotherapy with olmesartan
    Nachweis einer signifikant wirksameren Blutdrucksenkung nach 6 Wochen Therapie mit einer fixen Kombination aus Olmesartan 40 mg und Amlodipin 10 mg im Vergleich zur Monotherapie mit 32 mg Candesartan und die Sicherheit einer sequentiellen Therapieumstellung über eine zwischengeschaltete 6-wöchige Monotherapie mit Olmesartan 40 mg
    E.2.2Secondary objectives of the trial
    Comparison of OBDM and ABPM values with regard to achieving target bp values.

    Distribution of patients over different ABPM dipping regimes.
    Vergleich von Praxis-Blutdruck- und ABDM-Werte im Hinblick auf das Erreichen des Zielblutdrucks.

    Verteilung auf die vier Dipper-Typen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male or female patients >= 18 years of age

    essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out
    Frauen oder Männer ≥ 18 Jahre mit essentieller Hypertonie und Blutdruckwerten in der OBDM ≥ 140 mmHg systolisch zur Screening Visite 1 bei vorhergehender antihypertensiver Monotherapie oder ≥ 160 mm Hg systolisch ohne Vortherapie und ≥ 160 mm Hg systolisch am Ende der Auswaschphase
    E.4Principal exclusion criteria
    • systolic office bp > 180 mm Hg at screening visit
    • known hypertensive retinopathy GIII or IV
    • recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
    • type I diabetes or poorly controlled (HbA1c > 8) type II diabetes
    • chronic heart failure NYHA III or IV
    • prior stroke or TIA
    • creatinine clearance < 60 ml/min or condition after kidney transplant
    • moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
    • women of childbearing potential without effective contraception, pregnant or breastfeeding women
    • concomitant therapy with lithium
    • hemodynamically relevant mitral or aortic valve stenosis (>= II°) or hypertrophic obstructive cardiomyopathy
    • concomitant therapy with strong CYP3A4 inhibitors or inductors
    • african patients
    • concomitant severe psychiatric condition that might impair proper intake of study medication
    • life expectancy < 6 months
    • night shift workers
    • known other mandatory indication for treatment with antihypertensive medications
    • parallel participation in other clinical trials
    • Blutdruck systolisch > 180 mm Hg in der OBDM zur Screening Visite 1
    • Bekannte hypertensive Retinopathie G III oder IV
    • Myokardinfarkt innerhalb der letzten 4 Wochen bzw. Indikation für eine koronare oder periphere Revaskularisation
    • Typ 1 Diabetes mellitus, Typ 2 Diabetes mellitus mit schlechter Blutzuckereinstellung (HbA1c ≥ 8)
    • Herzinsuffizienz NYHA III und IV
    • Z. n. Schlaganfall oder transitorisch ischämische Attacke
    • Kreatinin-Clearance < 60 ml/min oder Z. n. Nierentransplantation
    • Patienten mit mäßiger oder stark eingeschränkter Leberfunktion (ALT oder AST oder Bilirubin mehr als 2-fach über den oberen Normwert)
    • Gebärfähige Fauen, ohne effektive Schwangerschaftsverhütung, Schwangere und stillende Mütter
    • Therapie mit Lithium
    • Hämodynamisch relevante Mitral-oder Aortenstenose (≥Grad II) bzw. Hypertrophe Obstruktive Kardiomyopathie
    • Gleichzeitige Therapie mit starken CYP3A4-Induktoren sowie starken CYP3A4-Inhibitoren
    • Patienten mit schwarzer Hautfarbe
    • Schwere psychiatrische Begleiterkrankung, die eine ordnungsgemäße Einnahme der Studienmedikation behindern könnte
    • Lebenserwartung < 6 Monate
    • Nachtschichtarbeiter
    • Bestehende andere absolute Indikation zur Gabe eines Medikamentes mit blutdrucksenkender Wirkung
    • Gleichzeitige Teilnahme in anderen klinischen Prüfungen
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in systolic daytime mean ABDM values after six weeks therapy with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan
    Senkung des systolischen Tagesmittelwertes in der ABDM nach 6 Wochen Therapie mit einer fixen Kombination aus Olmesartan 40mg und Amlodipin 10mg im Vergleich zur vorhergehenden Monotherapie mit Candesartan
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.
    Nach 6 Wochen Monotherapie mit Olmesartan und nachgeschalteten 6 Wochen Therapie mit einer fixen Kombination aus Olmesartan und Amlodipin.
    E.5.2Secondary end point(s)
    Reduction of systolic/diastolic office blood pressure and mean values (night-time and 24 h for systolic bp and day-time, night-time and 24 h for diastolic bp) after therapy change from candesartan to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.
    Comparison of office bp and ABPM measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value).
    Senkung des syst./diast. Blutdrucks in der OBDM und der Blutdruckmittelwerte in der ABDM nachts, über 24 Stunden sowie des diastolischen Tagesmittelwertes nach Umstellung von Candesartan auf die Fixkombination aus Olmesartan 40 mg und Amlodipin 10 mg.
    Vergleich der OBDM - mit den ABDM - Werten im Hinblick auf die Blutdruckzielwerterreichung (<140/90 mmHg in der OBDM; < 135/85 mmHg Tagesmittelwert).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.
    Nach 6 Wochen Monotherapie mit Olmesartan und nachgeschalteten 6 Wochen Therapie mit einer fixen Kombination aus Olmesartan und Amlodipin.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 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 concerned12
    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
    The trial may be interrupted or ended prematurely if sponsor and principal investigator agree that this is necessary with regard to the cost/risk ratio.
    The sponsor also reserves the right to end the trial for formal reasons (i. e. insufficient recruitment rates, non-compliance with timeline, unfulfilled agreements, missing or lacking documentation).
    Die gesamte Studie kann in Abstimmung zwischen Sponsor und dem Leiter der klinischen Prüfung unter Abwägung des Nutzen/Risiko-Verhältnisses unterbrochen oder beendet werden.
    Der Sponsor behält sich vor, die Studie jederzeit auch aus formellen Gründen zu beenden (z. B. mangelnde Rekrutierung, nicht eingehaltener Studienzeitplan, nicht erfüllte Vereinbarungen, fehlende oder mangelhafte Dokumentation).
    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 months8
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) No
    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 No
    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 state80
    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 Opinion2011-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-13
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