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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);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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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) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2016-004015-13
    Sponsor's Protocol Code Number:FMD-TRI-2016-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-004015-13
    A.3Full title of the trial
    A phase III, international, multicenter, randomized and openlabel study to evaluate the efficacy on LDLc and blood pressure reduction and safety of Trinomia® versus usual care in patients with high cardiovascular risk without previous cardiovascular event. The VULCANO trial.
    Estudio de fase III, internacional, multicéntrico, aleatorizado y abierto, para evaluar la eficacia en la reducción de cLDL y presión arterial, y la seguridad de Trinomia® versus tratamiento habitual en pacientes de muy alto riesgo cardiovascular sin evento previo: Estudio 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 high cardiovascular risk without previous cardiovascular event.
    Estudio para evaluar la eficacia en la reducción de los niveles de colesterol y presión arterial y la seguridad de Trinomia® frente al tratamiento habitual en pacientes con riesgo cardiovascular muy alto sin evento previo.
    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 100 mg/20 mg/10 mg
    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.3.4Pharmaceutical 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 100 mg/20 mg/5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional, S.A.
    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.3.4Pharmaceutical 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 100 mg/20 mg/2,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional, S.A.
    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.3.4Pharmaceutical 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 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.3.4Pharmaceutical 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
    High cardiovascular risk without previous cardiovascular event.
    Alto o muy alto riesgo cardiovascular sin evento previo
    E.1.1.1Medical condition in easily understood language
    Prevention of cardiovascular accidents
    Prevención de riesgo 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 19.0
    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 high cardiovascular risk without previous cardiovascular accident, during 16 weeks treatment if Trinomia® is similar to monocomponents given at the same time (equivalent therapeutical doses), in terms of Blood pressure and c-LDL levels.
    Determinar, en pacientes de alto o muy alto riesgo cardiovascular sin evento previo, si el tratamiento con la polipíldora Trinomia® durante un periodo de 16 semanas, es no inferior al tratamiento habitual por separado, en términos de cifras de PA (presión arterial) y de niveles plasmáticos de c-LDL.
    E.2.2Secondary objectives of the trial
    Percentage of patients with controlled BP and c-LDL after 16 weeks as per ESC.
    -Percentage of change in in BP and , c-LDL levels, total chol, c-HDL; c-no-HDL and triglicerids between baseline and week 16 values in both treatment group.
    -Risk evolution using SCORE and PCE calculator (as per ACC/AHA 2013 guidelines), in both treatment groups after 16 treatment weeks.
    -Safety of Trinomia® treatment and usual treatment, as per notified AA (including withdrow due to AA and SAEs, also death), and lab test reports with some laboratory abnormality.
    - Porcentaje de pacientes con control de PAS/PAD y c-LDL a las 16 semanas, según las cifras consideradas en la guía de prevención cardiovascular de la Sociedad Europea de Cardiología (ESC, por sus siglas en inglés)1.
    - Porcentaje de cambio en los niveles de PAS/PAD, c-LDL, colesterol total, c-HDL, c-no-HDL, y triglicéridos entre el valor basal y la semana 16 entre ambos grupos de tratamiento.
    - Evolución del riesgo mediante la puntuación SCORE y la calculadora PCE (Pooled Cohort Equations, según las guías ACC/AHA 2013), entre ambos grupos tras 16 semanas de tratamiento.
    - Seguridad del tratamiento con Trinomia® y del tratamiento habitual del paciente, basándose en la evaluación de los acontecimientos adversos (AAs) notificados (incluyendo las retiradas por AA y AA graves incluida la muerte), y los resultados de laboratorio anómalos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following criteria:
    -Men and women aged 18-75 years
    -Patients (or legal representative) willing and able to sign a written informed consent form.
    -Patients with high or very high cardiovascular risk without previous cardiovascular event meeting at least one of the following characteristics:
    -Patients with atherosclerosis diagnosed by invasive or not invasive techniques (including coronary angiography, nuclear imaging, stress echocardiography, carotid plaque by ultrasound) and taking as aortic aneurysm, atherosclerotic plaque in carotid arteries (or IMT ≥1,5 mm) 12 severely calcified coronary arteries (coronary calcium> 300 U Agaston) or ABI <0.9.
    -Patients diagnosed Diabetes Mellitus (I or II ) (or in treatment with oral hypoglycemic agents or insulin) with concomitant micro albumin in urine (30-300mg); protein in urine, or kidney failure. (GFR 30 y 60 ml/min using CKD-EPI method).
    -Patient who (per investigator opinion) have controlled LDL-col and BP and keeping in treatment with lipid-lowering (with at least an estatine) and stable antihypertensive (at least an ACE inhibitors or ARBs) during 3 months before randomization (minimum).
    -Patients who will not require a change in lipid-lowering and/or antihypertensive medication during 16 weeks after randomization.
    -Women who are fertile pregnancy urine test.
    Los pacientes deben cumplir todos los criterios que se exponen a continuación para que puedan ser considerados para participar en el estudio:
    1) Pacientes de ambos sexos, de entre 18 y 75 años.
    2) Pacientes (o representante legal) dispuestos y capaces de firmar un documento de consentimiento informado por escrito.
    3) Pacientes de alto o muy alto riesgo cardiovascular sin evento previo que cumplan al menos una de las siguientes características:
    3.a) Pacientes con aterosclerosis subclínica diagnosticada mediante técnicas invasivas o no invasivas (incluyendo angiografía coronaria, imagen nuclear, cardioresonancia de estrés, ecocardiografía de estrés, placa carotidea por ultrasonido), y entendiéndose como tal el aneurisma aórtico, placa de ateroma en carótidas (o IMT ≥1,5 mm)12, calcificación severa de coronarias (calcio coronario > 300 U Agaston) o ITB <0.9.
    3.b) Pacientes diagnosticados de diabetes mellitus (tipo 1 o 2) (o en tratamiento con antidiabéticos orales o insulina) y que presenten de forma concomitante hipertensión arterial.
    3.c) Pacientes diagnosticados de diabetes mellitus (tipo 1 o 2) (o en tratamiento con fármacos antidiabéticos orales o insulina), que presenten de forma concomitante microalbuminuria (30-300mg) o proteinuria
    3.d) Pacientes diagnosticados de hipertensión arterial y que presenten de forma concomitante alguna de las siguientes manifestaciones: hipertrofia ventricular izquierda (diagnosticada por criterios de ECG o ecocardiográficos), microalbuminuria (30-300 mg), proteinuria, o insuficiencia renal (FGe entre 30 y 60 ml/min según el método CKD-EPI).
    4) Pacientes que, a criterio del investigador, tengan un control adecuado del colesterol LDL y de su presión arterial, y que hayan mantenido un tratamiento hipolipemiante (con al menos una estatina) y antihipertensivo estable (con al menos un IECA o un ARA II) durante los 3 meses previos a la aleatorización.
    5) Pacientes que, a criterio del investigador, no vayan a precisar un cambio en la medicación hipolipemiante y/o antihipertensiva durante las 16 semanas siguientes a la aleatorización.
    6) Para mujeres en edad fértil, prueba de embarazo en orina negativa
    E.4Principal exclusion criteria
    Patients meeting any of the folowing criteria will be rejected from the study.
    - Patient with previous cardiovascular event clinically significant (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 Fontaine classification).
    -Contraindicated used of Trinomia®
    -Patients in hemodialysis treatment or severe kidney failure (Creatinine clearance <30ml/min).
    -Value of ALT/AST 3xULN or severe or active liver failure.
    -Patients hypersensitivity to any pill component (atorvastatin, ramipril and aspirin), soybeans, peanuts, or ACE inhibitors or salicylates other than ASA or ramipril.
    -Patients with background of asthma attacks or nasal polyps associated with asthma, or other allergic reactions due to aspirin or NSAIDs.
    -Patients with recurrent active peptic ulcer, history and / or gastric or intestinal bleeding, cerebrovascular bleeding or dyspepsia common history.
    -Patients with anemia or worsening hemoglobin 3 months prior to the study to suspect the presence of active bleeding and contraindicate the use of ASA.
    -Patients with hemophilia or other bleeding disorders.
    -Patients with myopathy, myalgia, myositis or rhabdomyolysis history of statin, or creatine kinase (CK)> 5 ULN (recommended not measure CK after hard exercise).
    -Patients with a angioedema background or coughdue to ACE inhibitors.
    -Patients with bilateral kidney artery stenosis or kidney artery stenosis in a single working kidney.
    -Patients with suspected familial hypercholesterolemia.
    -Patients with triglycerids>400mg/dl when patient is being included.
    -Patients diagnosed with congestive heart failure (class III-IV NYHA).
    -Patients who is not clinically correct to use Trinomia®(
    (Including atorvastatin 20 or 40 mg and ramipril 2.5 to 10 mg) as a treatment of LDL cholesterol level and blood pressure.
    -Patients in treatment withsome opf the following drugs: >3 antihypertensive, oral anticoagulants, and antiplatelets (except ASA), chronic treatment with NSAIDs, gemfibrozil, rifampicin, cyclosporine, aliskiren, methotrexate, telaprevir, tipranavir / ritonavir oral fusidic acid.
    - Patients with life expectancy < 2 years.
    -Patient pregnant, lactating or intend to become pregnant during the study and patients not taking valid contraceptive measures .
    -Patients with mental disease that limits their ability to self-care.
    -Patients with a medical history of drug or alcohol abuse.
    -Patients who are participating in another clinical trial.
    Los pacientes que cumplan cualquiera de los siguientes criterios serán excluidos de participar en el estudio:
    1) Paciente que haya sufrido un evento cardiovascular con evidencia clínica (incluyendo infarto de miocardio u otra forma de SCA, angina, revascularización miocárdica o de otro territorio vascular, ictus isquémico o hemorrágico o EAP sintomática (clase II a IV de clasificación de Fontaine).
    2) Pacientes en los que esté contraindicado el uso de Trinomia®, incluyendo lo siguiente:
    2.a) Pacientes con hemodiálisis o con insuficiencia renal grave (definida por aclaramiento de creatinina <30ml/min).
    2.b) Pacientes con elevación de ALT/AST > 3 veces el límite superior de normalidad (LSN) o con insuficiencia hepática grave o activa.
    2.c) Pacientes con hipersensibilidad a alguno de los componentes de la polipíldora (atorvastatina, ramipril y ácido acetilsalicílico), soja, cacahuetes, o a IECA o salicilatos distintos a ASA o ramipril.
    2.d) Pacientes con antecedentes de crisis asmáticas o pólipos nasales asociados a asma, u otras reacciones alérgicas debidas a AAS u otros AINEs.
    2.e) Pacientes con úlcera péptica recurrente activa, antecedentes y/o hemorragias gástrica o intestinal, hemorragia cerebrovascular, o historia habitual de dispepsia.
    2.f) Pacientes con anemia o empeoramiento de la hemoglobina en los 3 meses anteriores al estudio que haga sospechar la presencia de sangrado activo y que contraindique el uso de AAS.
    2.g) Pacientes con hemofilia u otros trastornos de la coagulación.
    2.h) Pacientes con miopatía, mialgia, miositis o antecedentes de rabdomiolisis por estatinas, o niveles de creatina kinasa (CK) >5 LSN (se recomienda no medir CK tras un ejercicio intenso).
    2.i) Pacientes con antecedentes de angioedema o tos por IECA.
    2.j) Pacientes con estenosis bilateral de arteria renal o estenosis de arterial renal con un solo riñón funcionante.
    3) Pacientes con sospecha de hipercolesterolemia familiar.
    4) Pacientes con nivel de triglicéridos >400mg/dl en el momento de la inclusión en el estudio.
    5) Pacientes con diagnóstico de insuficiencia cardíaca congestiva clase III-IV de la NYHA.
    6) Pacientes en los que, a criterio del investigador, no sea clínicamente adecuado utilizar Trinomia® (incluyendo atorvastatina 20 o 40mg y ramipril 2,5 a 10mg) como tratamiento para el control del cLDL y la presión arterial.
    7) Pacientes en tratamiento con alguno de los siguientes fármacos: en tratamiento con más de 3 antihipertensivos (estando permitido 3 antihipertensivos, pero no en una triple combinación fija), antiacoagulantes orales, antiagregantes (excepto AAS), tratamiento crónico con AINE (está permitido el tratamiento ocasional con AINE durante el estudio), gemfibrozilo, rifampicina, ciclosporina, aliskiren, metotrexato, telaprevir, tipranavir/ritonavir, ácido fusídico oral.
    8) Pacientes con cualquier condición que limite su expectativa de vida <2años.
    9) Pacientes embarazadas, lactantes o con intención de quedarse embarazadas durante el estudio, así como pacientes que no tomen medidas anticonceptivas válidas.
    10) Pacientes con enfermedad mental que limite su capacidad de auto-cuidado.
    11) Pacientes con historial médico de abuso de drogas o alcohol.
    12) Pacientes que estén participando en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is SBP evaluation and percentage of LDL-c levels changed between randomization and week 16.
    La variable principal de valoración es el cambio en las cifras absolutas de PAS y el porcentaje de cambio en los niveles plasmáticos de c-LDL desde la aleatorización hasta la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    SBP evaluation: In Screening(V1); Baseline(V2); Week 8 (V3); and Week 16 (EoT).
    LDL-c level (percentage of changing) In screening visit (V1) and week 16 (EoT)
    PAS/PAD: En screening (V1); Basal (V2); semana 8 (V3); y semana16 (EoT).
    c-LDL-level (porcentaje de cambio): en screening (V1) y semana 16 (EoT).
    E.5.2Secondary end point(s)
    -Total cholesterol, HDL-c; no HDL c and triglicerids between baseline and week 16.In screening and EoT.
    -SCORE scale and PCE calculator (baseline-W16)
    -Safety of Trinomia treatment is defined by notified SAEs, withdrawals due to AEs or SAEs (including death) during the study, and lab reports with abnormal values. (baseline and EoT)
    SBP evaluation: In Screening(V1); Baseline(V2); Week 8 (V3); and Week 16 (EoT).
    LDL-c level (percentage of changing) In screening visit (V1) and week 16 (EoT)
    - Cifras de PAS/PAD y niveles de c-LDL en el momento basal y a las 16 semanas.
    - Niveles de colesterol total, c-HDL, c-no-HDL y triglicéridos en el momento basal y a las 16 semanas.
    - Puntuación SCORE y PCE (según las Guías ACC/AHA 2013) en el momento basal y a las 16 semanas.
    - La variable secundaria de seguridad vendrá definida por los acontecimientos adversos (AAs) notificados, retiradas por AA y AA graves (incluida la muerte), y resultados de laboratorio anómalos ocurridos durante todo el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Value of SBP/DBP and LDL-c levels between baseline and week 16 of treatment.
    -Total cholesterol, HDL-c; no HDL c and triglicerids between baseline and week 16.
    -SCORE scale and PCE calculator (baseline-W16).
    -Safety of Trinomia treatment is defined by notified SAEs, withdrawals due to AEs or SAEs (including death), and lab reports with abnormal values.
    Cifras de PAS/PAD y niveles de c-LDL en el momento basal y a las 16 semanas.
    - Niveles de colesterol total, c-HDL, c-no-HDL y triglicéridos en el momento basal y a las 16 semanas.
    - Puntuación SCORE y PCE (según las Guías ACC/AHA 2013) en el momento basal y a las 16 semanas.
    - La variable secundaria de seguridad vendrá definida por los acontecimientos adversos (AAs) notificados, retiradas por AA y AA graves (incluida la muerte), y resultados de laboratorio anómalos ocurridos durante todo el estudio.
    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 concerned32
    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.
    Cierre de la base de datos.
    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 state360
    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
    Práctica 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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-11
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