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Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-004015-13
    Sponsor's Protocol Code Number:FMD-TRI-2016-01
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-15
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2016-004015-13
    A.3Full title of the trial
    A phase III, international, multicenter, randomized and open label study to evaluate the efficacy on LDLc and blood pressure reduction and safety of Trinomia® versus usual care in patients with very high cardiovascular risk without previous cardiovascular event. The VULCANO trial
    Estudo de Fase III, internacional, multicêntrico, aleatorizado e aberto, para avaliar a eficácia na redução do cLDL e da pressão arterial, e a segurança de Trinomia® versus tratamento habitual em doentes de risco cardiovascular muito alto sem evento prévio: Estudo VULCANO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the efficacy on cholesterol and blood pressure reduction and safety of Trinomia® versus usual care in patients with very high cardiovascular risk without previous cardiovascular event.
    Estudo para avaliar a eficácia e segurança de Trimonia® na redução dos níveis de colesterol e pressão arterial versus o tratamento habitual em doentes com risco cardiovascular muito alto sem evento prévio.
    A.3.2Name or abbreviated title of the trial where available
    VULCANO
    VULCANO
    A.4.1Sponsor's protocol code numberFMD-TRI-2016-01
    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 SponsorFerrer Internacional, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFerrer Internacional, S.A.
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFerrer Internacional, S.A.
    B.4.2CountryMexico
    B.4.1Name of organisation providing supportFerrer Internacional, S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointDepartamento de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-maila.tello@dynasolutions.com
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional SA
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 Capsule, hard
    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 INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 Capsule, hard
    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 INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 Capsule, hard
    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 INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTrinomia 100 mg/40 mg/10 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INN5561
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTrinomia 100 mg/40 mg/5 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INN5561
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 6
    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 Trinomia
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTrinomia 100 mg/40 mg/2,5 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INN5561
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameRAMIPRIL
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 7
    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 Usual Care - treatment for cardiovascular prevention: antiplatelet, lipid-lowering and blocking agents of the renin-angiotensin-aldosterone system.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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
    Very high cardiovascular risk without previous cardiovascular event
    Risco cardiovascular muito alto sem evento prévio
    E.1.1.1Medical condition in easily understood language
    Cardiovascular risk prevention
    Prevenção de risco cardiovascular
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064939
    E.1.2Term Cardiovascular event prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determinate in patients with very high cardiovascular risk without previous cardiovascular event, after a 16 weeks treatment period, if Trinomia® is at least similar to monocomponents given at the same time (equivalent therapeutical doses), in terms of Systolic Blood Pressure and LDLc plasma levels.
    Determinar, em doentes de risco cardiovascular muito alto sem evento prévio, se o tratamento com a polypill Trinomia® depois de um período de 16 semanas é pelo menos não-inferior ao tratamento habitual por separado, em termos de valores de PAS (Pressão Arterial Sistólica) e de níveis plasmáticos de c-LDL.
    E.2.2Secondary objectives of the trial
    - To compare percentage of patients with controlled SBP /DBP and LDLc at 16 weeks, as per ESC guidelines, between both groups.
    - To compare percentage of change in SBP /DBP and percentage of change in LDLc levels, total cholesterol, HDLc, non-HDL cholesterol and triglycerides between baseline and week 16 values, in each group and between both treatment groups.
    - Assess the risk by using SCORE (only in patients up to 79 years of age), between both groups after 16 weeks of treatment.
    - Assess the safety of Trinomia® treatment and the usual treatment of the patient, as per notified AAs (including withdraw due to AAs and SAEs, including death), and abnormal laboratory test results with clinical relevance.
    - Comparar percentagem de doentes com controlo PAS / PAD e c-LDL às 16 semanas, de acordo com valores considerados no guia de prevenção cardiovascular da Sociedade Europeia de Cardiologia (ESC), entre ambos os grupos.
    - Comparar a variação percentual nos níveis de PAS / PAD e a percentagem de variação em c-LDL, colesterol total, c-HDL, colesterol não-HDL e triglicéridos entre o valor basal e a semana 16, em cada grupo e entre os dois grupos de tratamento.
    - Avaliar o risco mediante a pontuação SCORE (apenas em doentes até aos 79 anos), entre ambos os grupos após 16 semanas de tratamento.
    - Avaliar a segurança do tratamento com Trinomia® e do tratamento habitual do doente, com base na avaliação dos acontecimentos adversos (AAs) notificados (incluindo os abandonos por AA e AA graves, incluída a morte), e os resultados laboratoriais anómalos com importância clínica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following criteria:
    1) Patients of both sexes, older than 18 years.
    2) Patients willing and able to sign a written informed consent form.
    3) Patients with high or very high cardiovascular risk, without previous cardiovascular event (the definition of high or very high cardiovascular risk is in accordance with the european guidelines for cardiovascular prevention) and meeting at least one of the following characteristics:
    3.a) Patients with subclinical atherosclerosis diagnosed by invasive or not invasive techniques (including coronary angiography, nuclear imaging, stress cardiac resonance imaging, stress echocardiography, CT scan of coronary arteries, carotid plaque by ultrasound) and taking as aortic aneurysm, atherosclerotic plaque in carotid arteries (or IMT ≥1,5 mm); severely calcified coronary arteries (coronary calcium> 300 U Agaston) or ABI <0.9.
    3.b) Patients diagnosed with Diabetes Mellitus (I or II) or in treatment with oral hypoglycemic agents or insulin and with concomitant hypertension.
    3.c) Patients diagnosed with Diabetes Mellitus (I or II) or in treatment with oral hypoglycemic agents or insulin and with concomitant albumin or protein in urine.
    3.d) Patients diagnosed with hypertension (or treated with antihypertensive drugs) with one of the following concomitant clinical situations: left ventricular hypertrophy (diagnosed by electrocardiogram or ecocardiogram; left ventricular mass index > 95g/m^2 in female and > 115g/m^2 in male or interventricular septum > 11 mm),albumin or protein in urine or renal failure (GFR between 30 and 60 mL /min according to the CKD-EPI method).
    4) Patients who, per investigator's opinion, have controlled LDL cholesterol and BP and kept in treatment with a stable lipid-lowering (with at least one estatine) and antihypertensive treatment (at least one ACE inhibitor or one ARB) during 3 months before randomization.
    5) Patients who, per investigator's opinion, will not require a change in their lipid-lowering and/or antihypertensive medication during the 16 weeks after randomization.
    6) For women with childbearing potential, there is a negative pregnancy test (urine).
    Os doentes devem cumprir todos os critérios descritos a seguir:
    1) Doentes de ambos sexos, maiores de 18 anos.
    2) Doentes dispostos e aptos para fornecer um documento de consentimento informado por escrito.
    3) Doentes de risco cardiovascular alto ou muito alto, sem evento prévio (a definição de risco cardiovascular alto ou muito alto, está de acordo com a guideline europeia para a prevenção cardiovascular) que cumpram pelo menos com uma das seguintes características:
    3.a) Doentes com aterosclerose subclínica diagnosticada mediante técnicas invasivas ou não invasivas (incluindo angiografia coronária, imagem nuclear, cardioressonância sob stress, ecocardiografia sob stress, TAC das coronárias, placa carotídea por ultrassonografia), e entendendo-se como tal o aneurisma aórtico, placa de ateroma nas carótidas (ou IMT =1,5 mm); calcificação severa das artérias coronárias (cálcio coronário> 300 U Agaston) ou ITB <0.9.
    3.b) Doentes com diagnóstico de diabetes mellitus (tipo 1 ou 2) ou em tratamento com fármacos orais ou insulina e que apresentem de forma concomitante hipertensão arterial.
    3.c) Doentes com diagnóstico de diabetes mellitus (tipo 1 ou 2) ou em tratamento com fármacos antidiabéticos orais ou insulina, que apresentem de forma concomitante albuminúria ou proteinúria.
    3.d) Doentes com diagnóstico de hipertensão arterial (ou em tratamento com fármacos para o controlo da pressão arterial) que apresentem concomitantemente alguma das seguintes manifestações: hipertrofia ventricular esquerda (diagnosticada por critérios eletrocardiográficos ou ecocardiográficos; índice de massa ventricular esquerdo > 95g/m2 no sexo feminino e > 115g/m2 no sexo masculino ou septo interventricular > 11 mm), albuminúria, proteinúria, ou insuficiência renal (FGe entre 30 e 60 mL/min segundo o método CKD-EPI).
    4) Doentes que, segundo critério do investigador, mantenham um controlo adequado do colesterol LDL e da sua pressão arterial, e que tenham mantido um tratamento hipolipemiante (pelo menos com uma estatina) e antihipertensor (pelo menos com um IECA ou um ARA II) estável durante os 3 meses prévios à aleatorização.
    5) Doentes que, segundo critério do investigador, não vão precisar de uma alteração na medicação hipolipemiante e/ou antihipertensora nas 16 semanas após a aleatorização.
    6) Para mulheres em idade fértil, existir um teste de gravidez negativo (urina).
    E.4Principal exclusion criteria
    Patients meeting any of the folowing criteria will be rejected from the study:
    1) Patient with previous clinically significant cardiovascular event (including myocardial infarction or other form of acute coronary syndrome, angina, myocardial revascularization or other vascular territory, ischemic or hemorrhagic stroke or symptomatic DBP (class II to IV by Fontaine classification).
    2) Patients with contraindicated used of Trinomia®, including the following:
    2.a) Patients in hemodialysis treatment or severe kidney failure (defined by glomerular filtration (calculated by using the CKD-EPI formula) <30ml/min).
    2.b) Patients with ALT / AST values > 3xULN or with severe or active liver failure.
    2.c) Patients hypersensitivity to any polypill component (atorvastatin, ramipril and aspirin), soybeans, peanuts, or ACE inhibitors or salicylates other than ASA or ramipril.
    2.d) Patients with history of asthma attacks or nasal polyps associated with asthma, or other allergic reactions due to aspirin or other NSAIDs.
    2.e) Patients with recurrent active peptic ulcer, history of gastric or intestinal bleeding, cerebrovascular bleeding or dyspepsia.
    2.f) Patients with anemia or worsening in hemoglobin levels that, per investigator's assessment, make them suspect of the presence of active bleeding and thet contraindicate the use of ASA.
    2.g) Patients with hemophilia or other bleeding disorders.
    2.h) Patients with myopathy, myalgia, myositis or rhabdomyolysis history due to statins, or those who have a creatine kinase (CK) analysis whose result is > 5 ULN (recommended not measuring CK after intense exercise).
    2.i) Patients with an angioedema or cough history due to ACE inhibitors.
    2.j) Patients with bilateral kidney artery stenosis or kidney artery stenosis in a single working kidney.
    3) Patients with grade III arterial hipertension (systolic blood pressure > 180 and / or diastolic blood pressure > 110mmHg).
    4) Patients with suspected or diagnosed familial hypercholesterolemia.
    5) Patients with triglycerides levels > 400mg/dl when patient is being included.
    6) Patients diagnosed with congestive heart failure (NYHA class III-IV).
    7) Patients who, per investigator's opinion, are not clinically appropriate to use Trinomia® (including atorvastatin 20 or 40 mg and ramipril 2.5 to 10 mg) as treatment for the control of LDLc and blood pressure.
    8) Patients being treated with any of the following drugs: fixed dose combination of 3 antihypertensives (for patients that, at baseline, are in combination of antihypertensives which include ACEi/ASA II with calcium channel blockers, please refer to section 6.2 Ground Dose Justification), oral anticoagulants, antiplatelet agents (except ASA), chronic treatment with NSAID (occasional treatment with NSAID during the study is allowed (occasional use is considered when using ibuprofen (maximum dose of 1200mg/d) or other NSAID at an equivalent dose, for a maximum of 3 days in a one month period), CYP3A4 Inhibitors transport proteins (cyclosporine, rifampicin, telitromicine, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, telaprevir, etc.), other medication such as: gemfibrozil, aliskiren, methotrexate, (oral) fusidic acid, sacubitril/valsartan.
    9) Patients with severe systemic disease who, per investigator's opinion, may interfere with the study procedures and assessments.
    10) Patients who are pregnant, nursing or intending to become pregnant during the study, as well as fertile women who do not take valid contraceptive measures (such as: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner or sexual abstinence. In those fertile women, additional pregnancy testing should be performed at monthly intervals.
    11) Patients with mental illness (such as dementia) or living in a nursing home or committed to an institution by virtue of an order issued by the judicial or administrative authorities that may limit their capacity of self care.
    12) Patients with a medical history of drug or alcohol abuse.
    13) Patients who have participated in another clinical trial within 30 days prior to randomization.
    14) Patients treated with Trinomia prior to randomization.
    Os doentes que cumpram qualquer dos seguintes critérios serão excluídos de participar no estudo:
    1) Doente que tenha sofrido um evento cardiovascular com evidência clínica (incluindo enfarte do miocárdio ou outra forma de SCA, angina de peito, revascularização miocárdica ou de outro território vascular, AVC isquémico ou hemorrágico ou DAP sintomática (classe II a IV da classificação de Fontaine).
    2) Doentes para os quais está contraindicado o uso de Trinomia®, incluindo o seguinte:
    2.a) Doente em hemodiálise ou com insuficiência renal severa (definida por filtração glomerular (calculada pela fórmula CKD-EPI) <30 ml/min).
    2.b) Doentes com elevação dos valores laboratoriais de ALT/AST > 3 vezes o limite superior de normalidade (LSN) ou com insuficiência hepática grave ou activa.
    2.c) Doente com hipersensibilidade a algum dos componentes da polypill (atorvastatina, ramipril e ácido acetilsalicílico), soja, amendoins, ou a IECA ou salicilatos diferentes de ASA ou ramipril.
    2.d) Doentes com antecedentes de crises asmáticas ou pólipos nasais associados a asma, ou outras reacções alérgicas a AAS ou a outros AINEs.
    2.e) Doentes com úlcera péptica recorrente activa, antecedentes de hemorragia gástrica ou intestinal, hemorragia cerebrovascular, ou história habitual de dispepsia.
    2.f) Doentes com anemia ou agravamento da hemoglobina que, de acordo com a avaliação do investigador, faça suspeitar a presença de hemorragia activa e que contraindique a utilização de AAS.
    2.g) Doentes com hemofilia ou outros transtornos relacionados com a coagulação.
    2.h) Doentes com miopatia, mialgia, miosite ou antecedentes de rabdomiólise por estatinas, ou aqueles que disponham de análise de creatina quinase (CK) cujo resultado seja > 5 LSN (recomenda-se não medir CK após exercício intenso).
    2.i) Doentes com antecedentes de angioedema ou tosse por IECA.
    2.j) Doentes com estenose bilateral da artéria renal, ou estenose da artéria renal com um único rim funcionante.
    3) Doentes com hipertensão arterial grau III (pressão arterial sistólica > 180 e/ou pressão arterial diastólica > 110 mmHg).
    4) Doentes com suspeita ou diagnóstico definitivo de hipercolesterolemia familiar.
    5) Doentes com níveis de triglicéridos > 400 mg/dL no momento da inclusão no estudo.
    6) Doentes com diagnóstico de insuficiência cardíaca congestiva classe III-IV NYHA.
    7) Doentes aos quais, na opinião do investigador, não é clinicamente adequado utilizarem Trinomia® (incluindo atorvastatina 20 mg ou 40 mg e ramipril 2,5 a 10 mg) como tratamento para o controlo do cLDL e da pressão arterial.
    8) Doentes em tratamento com algum dos seguintes fármacos: combinação de dose fixa de 3 anti-hipertensores (para doentes que na baseline estejam em combinação de antihipertensores, que incluam IECA/ARA II com antagonista dos canais de cálcio, ver por favor secção 6.2 Justificação da Dose Inicial), anticoagulantes orais, antiagregantes (excepto AAS), tratamento crónico com AINE (é permitido o tratamento ocasional com AINE durante o estudo (considera-se uso ocasional quando se usa o ibuprofeno (dose máxima de 1200mg/d) ou outro AINE em dose equivalente, durante o máximo de 3 dias no período de um mês), inibidores de CYP3A4 ou do transporte de proteínas (ciclosporina, rifampicina, telitromicina, claritromicina, delavirdina, estiripentol, cetoconazol, voriconazol, itraconazol, posaconazol e inibidores da protease de VIH como ritonavir, lopinavir, atazanavir, indinavir, darunavir, telaprevir, etc.), outros medicamentos como: gemfibrozil, aliskiren, metotrexato, ácido fusídico (oral) ou sacubitril/valsartan.
    9) Doentes com doença sistémica grave e que, na opinião do investigador, poderá interferir com os procedimentos e avaliações do estudo.
    10) Doentes grávidas, lactantes, ou com intenção de engravidar durante o estudo, bem como doentes que não adotem medidas anti contracetivas válidas (como: contracepção hormonal combinada (estroprogestativos) associada à inibição da ovulação (administração oral, vaginal ou transdérmica), contracepção hormonal com progestativos isolados associada à inibição da ovulação (oral, injetável ou implantável), dispositivos intrauterinos, dispositivos intrauterinos medicados, oclusão tubária bilateral, parceiro vasectomizado ou abstinência sexual. No caso de mulheres em idade fértil devem realizar-se testes de gravidez em intervalos mensais.
    11) Doentes com doença mental (como demência) ou que vivem institucionalizados ou que estão sob uma qualquer ordem emitida pelas autoridades judiciais ou administrativas que pode limite a sua capacidade autónoma.
    12) Doentes com história clínica de abuso de drogas ou álcool.
    13) Doentes que tenham participado noutro ensaio clínico num período < 30 dias antes da aleatorização.
    14) Doentes tratados com Trinomia® antes da aleatorização.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary end points are SBP values and plasma LDLc levels at 16 weeks of treatment.
    As covariáveis principais de avaliação são os valores absolutos de PAS e os níveis plasmáticos de c-LDL às 16 semanas de tratamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - SBP values in screening(V1), baseline(V2) and week 16 (EoT).
    - plasma LDLc levels in screening visit (V1) and week 16 (EoT).
    - valores absolutos de PAS/PAD no screening (V1), na baseline (V2) e na semana16 (EoT).
    - níveis plasmáticos de c-LDL no screening (V1) e na semana 16 (EoT).
    E.5.2Secondary end point(s)
    - Differences in SBP / DBP and LDLc levels between the screening visit and the 16 weeks of treatment.
    - Differences in total cholesterol, HDLc, non-HDLc and triglycerides levels between the baseline visit and at 16 weeks of treatment.
    - Difference in SCORE scale at baseline and at 16 weeks of treatment.
    - Secondary safety variables will be defined by notified adverse events (AAs), withdrawals due to AAs and SAEs (including death) and laboratory abnormalities occurring throughout the study.
    - Diferenças nos valores de PAS / PAD e nos níveis de LDL-C entre a visita de início do estudo e as 16 semanas de tratamento.
    - Diferenças nos níveis de colesterol total, c-HDL, c-não HDL e triglicéridos basais e às 16 semanas de tratamento.
    - Diferença no SCORE no início e às 16 semanas de tratamento.
    - As variáveis secundárias de segurança serão definidas por eventos adversos (AAs) relatados, abandonos por AA e AA graves (incluindo morte) e alterações laboratoriais ocorridos ao longo do estudo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - SBP / DBP values and LDLc levels in screening visit (V1) and week 16 (EoT).
    - Total cholesterol, HDLc, no-HDLc and triglycerides in screening visit (V1) and week 16 (EoT).
    - SCORE scale in baseline(V2) and week 16 (EoT).
    - reporting adverse events (AAs), withdrawals due to AAs and SAEs (including death) and laboratory abnormalities occurring throughout the study.
    - valores de PAS / PAD e níveis de LDL-C no screening (V1) e e na semana16 (EoT).
    - níveis de colesterol total, c-HDL, c-não HDL e triglicéridos no screening (V1) e e na semana16 (EoT).
    - SCORE na baseline (V2) e na semana16 (EoT).
    - reportar eventos adversos (AAs) relatados, abandonos por AA e AA graves (incluindo morte) e alterações laboratoriais ao longo do estudo.
    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 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) 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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Mexico
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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
    Database closure.
    Encerramento da base de dados
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 414
    F.4.2.2In the whole clinical trial 500
    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)
    Usual care
    Prática clínica habitual
    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 Decision2017-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-11
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