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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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2014-005378-12
    Sponsor's Protocol Code Number:CL3-05153-006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005378-12
    A.3Full title of the trial
    Efficacy and Safety of Fixed-Dose Combination
    atorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.
    Efficacy and Safety of Fixed-Dose Combination
    atorvastatin/amlodipine/perindopril versus Fixed-Dose Combination of
    atorvastatin/ amlodipine in Patients with Hypertension and Dyslipidemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Fixed-Dose Combination
    atorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.
    Efficacia e sicurezza dell¿associazione a dose fissa di atorvastatina / amlodipina / perindopril versus l¿associazione a dose fissa di atorvastatina / amlodipina in pazienti con ipertensione e dislipidemia
    A.3.2Name or abbreviated title of the trial where available
    Not available
    Non disponibile
    A.4.1Sponsor's protocol code numberCL3-05153-006
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1166-2705
    A.5.4Other Identifiers
    Name:NDNumber:CL3-05153-006
    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 SponsorINSTITUT DE RECHERCHES INTERNATIONALES SERVIER
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO DI RICERCA SERVIER S.R.L.
    B.5.2Functional name of contact pointProject Manager Sabrina Ceccotti
    B.5.3 Address:
    B.5.3.1Street AddressVia Luca Passi, 85
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00166
    B.5.3.4CountryItaly
    B.5.4Telephone number06669081
    B.5.5Fax number0666908738
    B.5.6E-mailinfoirs@netgrs.it
    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 Triveram
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 INNPERINDOPRIL
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB23191
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Triveram
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoire Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 INNPERINDOPRIL
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB23191
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Triveram
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoire Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 INNPERINDOPRIL
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB23191
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ILACLARI LTD. STI
    D.2.1.2Country which granted the Marketing AuthorisationTurkey
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ILACLARI LTD. STI
    D.2.1.2Country which granted the Marketing AuthorisationTurkey
    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 IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER AUSTRALIA PTY LTD
    D.2.1.2Country which granted the Marketing AuthorisationTurkey
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER KOREA
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB12864MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 8
    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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Malaysia
    D.2.1.2Country which granted the Marketing AuthorisationMalaysia
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 9
    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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria Ges.m.b.H., Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 10
    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 CADUET
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Korea
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 INNATORVASTATINA
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12958MIG
    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 INNAMLODIPINA
    D.3.9.2Current sponsor codeND
    D.3.9.4EV Substance CodeSUB12864MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertension and dyslipidemia
    Ipertensione e dislipidemia
    E.1.1.1Medical condition in easily understood language
    Hypertension and dyslipidemia
    Ipertensione e dislipidemia
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10020774
    E.1.2Term Vascular hypertensive disorders NEC
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of oral fixed-dose combination atorvastatin/amlodipine/perindopril versus the reference drug atorvastatin/amlodipine in lowering office sitting systolic blood pressure (SBP) after 12 weeks of treatment (W012) versus baseline (W012-W000).
    Dimostrare la superiorit¿ del trattamento orale a dose fissa dell'associazione atorvastatina / amlodipina / perindopril versus il farmaco di riferimento atorvastatina / amlodipina nel ridurre la pressione sistolica arteriosa (SBP) ambulatoriale in posizione seduta dopo 12 settimane di trattamento (visita W012) rispetto alla misurazione baseline (W012-W000)
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of atorvastatin / amlodipine / perindopril versus atorvastatin / amlodipine in lowering Diastolic Blood Pressure (DBP) after 12 weeks of treatment versus baseline (W012-W000).
    -To assess the efficacy of atorvastatin/ amlodipine/ perindopril in lowering Low Density Lipoprotein-Cholesterol (LDL-c) after 12 weeks of treatment versus baseline (W012-W000) within group
    -To assess the safety of each dose of atorvastatin/ amlodipine/ perindopril during the study and at the end of the treatment period (W012).
    -Verificare l¿efficacia dell' associazione atorvastatina /amlodipina/ perindopril versus atorvastatina /amlodipina nel ridurre la pressione diastolica arteriosa (DBP) dopo 12 settimane di trattamento rispetto alla misurazione baseline (W012-W000)
    -Verificare l¿efficacia dell'associazione atorvastatina /amlodipina/ perindopril nel ridurre il Colesterolo ¿Lipoproteine a bassa Densit¿ (LDL-c) dopo 12 settimane di trattamento rispetto alla baseline (W012-W000) ,
    -Verificare la sicurezza di ciascuna dose dell'associazione atorvastatina / amlodipina / perindopril durante lo studio e alla fine del periodo di trattamento (W012).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Men or women of any ethnic origin aged 40 to 79 years inclusive who have signed the informed consent form and can comply with the study requirements and timetable.
    2-Essential hypertension defined as: Hypertensive patients naïve of treatment with 160 mmHg = SBP <180 mmHg and 100 mmHg = DBP < 110 mmHg or isolated systolic hypertension (160 mmHg = SBP <180 mmHg) or
    Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril 10mg or amlodipine 10mg) for combined systolic and diastolic hypertension (150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg) or isolated systolic hypertension (150 mmHg = SBP < 180 mmHg)
    3-Dysplipidemic patients : naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 130 mg/ Decilitre (dL) (or 3.36 millimole [mmol] /L) = LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a prevous laboratory result within 12 months
    4-Confirmed hypertension measured at inclusion: 150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg or isolated systolic hypertension 150 mmHg = SBP < 180 mmHg for either patients under prior monotherapy treatment or patients naive of treatment
    5-Confirmed dyslipidemia on lipid profile assessed at W0 visit: 130 mg/dL = LDL-c < 190 mg/dL
    1-Uomini o donne di qualunque origine etnica con età compresa tra 40 e 79 anni inclusi, che hanno firmato il consenso informato e che rispettano i criteri e la tempistica dello studio
    2-Ipertensione essenziale definite come:
    - Pazienti ipertesi naïve al trattamento con 160 mmHg = SBP <180 mmHg e 100 mmHg = DBP < 110 mmHg o ipertensione sistolica isolata (160 mmHg = SBP <180 mmHg) oppure
    - Pazienti ipertesi non controllati e in trattamento, con monoterapia da almeno 4 settimane (eccetto pazienti trattati con perindopril 10mg o amlodipine 10mg) con ipertensione sistolica e diastolica combinata (150 mmHg = SBP < 180 mmHg e 95 mmHg = DBP< 110 mmHg) o ipertensione sitolica isolata (150 mmHg = SBP< 180 mmHg), e
    3-Pazienti dislipidemici: naïve al trattamento o non controllati con statina alla dose più bassa da almeno 4 settimane con un valore 130 mg/dL (o 3.36 mmol /L) = LDL-c< 190 mg/dL (o 4.91 mmol/L) come evidenziato da precedenti risultati di laboratorio ottenuti entro i 12 mesi
    4-Conferma dell’ipertensione misurata alla visita W000 come: 150 mmHg = SBP< 180 mmHg e 95 mmHg = DBP< 110 mmHg oppure ipertensione sitolica isolata 150 mmHg = SBP < 180 mmHg sia per i pazienti in trattamento monoterapico che per quelli naive al trattamento
    5-Conferma della dislipidemia con verifica del profilo lipidico valutato alla visita W000 come: 130 mg/dL=LDL-c< 190 mg/dL
    E.4Principal exclusion criteria
    1-Known symptomatic orthostatic hypotension
    2-Secondary hypertension
    3-Isolated diastolic hypertension defined as DBP > or = 90 mmHg
    4-Known complicated hypertension: known stage III or IV hypertensive retinopathy, microalbuminaria
    5-Known diabetes mellitus type I or type II
    6-Obesity defined as a body mass index = 32 kg/m2
    7-History or current presence of lymphedema or leg edema (unilateral or bilateral) of venous origin: previously known or discovered during the clinical examination at the selection visit, due to but not limited to calcium channel blockers, especially amlodipine (which induced amlodipine dose down titration or treatment stop)
    8-Any history of stroke, transient ischemic attack, cerebrovascular surgery or history of coronary artery disease; heart failure (New York Heart Association [NYHA] II-IV), or hypertrophic obstructive myocardiopathy; unstable angina
    9-Known ventricular rhythm disorders (except premature ventricular extrasystole less frequent than 6/minute); history of atrial fibrillation or atrial flutter (except if cured e.g. ablation without no new episodes within the last 12 months) or second or third degree A-V block or other cardiac rhythm disorders leading to important beat to beat variations in blood pressure or known valvular diseases (except mitral valve prolapse)
    10-Known renal impairment moderate or severe (known creatinine clearance <60 mL/mn), or bilateral renal artery stenosis or stenosis to a solitary kidney
    11-Contraindications to calcium channel inhibitors and/or to ACE inhibitors and/or to statins and especially: known allergy/hypersensitivity/history of intolerance, muscular toxicity during a treatment with a statin, hereditary or idiopathic angioedema, or history of angioedema associated with previous ACE inhibitor therapy
    12-Any other medication which may be used for the treatment of hypertension, but which is currently being taken by the patient for an alternative indication, and which cannot be discontinued at the selection visit
    13-History of myopathy, familial history of hereditary muscular disorders
    1-Ipertensione ortostatica sintomatica nota
    2-Ipertensione secondaria
    3-Ipertensione diastolica isolata definita come DBP= 90 mmHg
    4-Storia di ipertensione complicata come: conosciuta retinopatia ipertensiva di grado III o IV, microalbuminuria
    5-Storia di diabete mellito di tipo I o tipo II
    6-Obesità definita come indice di massa corporea = 32 kg/m2
    7-Storia conosciuta o presenza attuale di linfoedema o edema alle gambe (unilaterale o bilaterale) di origine venosa: conosciuta precedentemente o scoperta durante l’esame clinico nella visita di selezione, dovuto ad amlodipina o a qualunque farmaco che blocca i canali del calcio, e che ha indotto la diminuzione del dosaggio di amlodipina o interruzione del trattamento
    8-Storia di ictus, attacchi ischemici transienti, chirurgia cerebrovascolare o storia di malattia arterica coronarica; scompenso cardiaco (New York Heart Association [NYHA] II-IV), o miocardiopatia ipertrofica ostruttiva; angina instabile
    9-Storia di disordini nel ritmo ventricolare (eccetto extrasistole prematura ventricolare con frequenza minore di 6/minuto); storia di flutter o fibrillazione atriale (a meno che sia stata curata con ad es. ablazione senza nuovi episodi entro gli ultimi 12 mesi) o blocco A-V di secondo o terzo grado o altri disordini del ritmo cardiaco che comportano significative variazioni beat-to-beat nella pressione arteriosa o malattie valvolari conosciute (eccetto prolasso della valvola mitrale)
    10-Storia di disfunzioni renali moderate o gravi (valore di clearance creatinina <60 mL/mn), o stenosi bilaterale dell’arteria renale o stenosi dell arteria di rene unico
    11-Controindicazioni per gli inibitori dei canali del calcio e/o agli ACE inibitori e/o a statine ed in particolare: conosciute allergie /ipersensibilità/ intolleranze, tossicità muscolare durante un trattamento con una statina, angioedema ereditario o idiopatico, o storia di angioedema associato a precedenti terapie con ACE inibitori
    12-Qualsiasi altro farmaco usato per il trattamento dell’ipertensione, ma che è attualmente assunto dal paziente per un'altra indicazione che non può essere interrotto alla visita di selezione
    13-Storia di miopatie, storia di disordini familiari muscolari ereditari
    E.5 End points
    E.5.1Primary end point(s)
    Office sitting Sistolic blood pressure( SBP) measured within 24 ± 3 hours after the last drug intake in the Investigator’s office using an automated validated device
    SBP misurata in posizione seduta nel centro sperimentale entro 24 ± 3 ore dopo l’ultima assunzione del farmaco in studio usando un dispositivo automatizzato validato
    E.5.1.1Timepoint(s) of evaluation of this end point
    All visits (W000,W004 e W012)
    Tutte le visite (W000,W004 e W012)
    E.5.2Secondary end point(s)
    Efficacy. Office sitting DBP measured within 24 ¿ 3 hours after the last drug intake in the Investigator¿s office using an automated validated device; Efficacy. Change from baseline over 12 weeks in LDL-c, total cholesterol, high density lipoprotein-c (HDL-c), and triglycerides; Safety. Adverse events; Safety. Vital signs including BP postural changes ; Safety. Clinical laboratory parameters (biochemistry and haematology); Safety. Electrocardiogram (ECG)
    Efficacia. DBP misurata in posizione seduta nel centro sperimentale entro 24 ¿ 3 ore dopo l¿ultima assunzione del farmaco in studio usando un dispositivo automatizzato validato; Efficacia. Differenza dei valori di LDL-c, colesterolo totale, HDL-c e trigliceridi alla visita W012 paragonati alla visita iniziale di selezione.; Sicurezza. Eventi Avversi; Sicurezza. Segni vitali inclusi i cambiamenti di BP posturale; Sicurezza. Parametri clinici di laboratorio (biochimica ed ematologia); Sicurezza. Elettrocardiogramma (ECG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All visits (W000, W004 e W012); Inclusion W004 and W012; All visits; All visits; At W004; Inclusion and W012
    Tutte le visite (W000, W004 e W012); Inclusione W004 e W012; Tutte le visite; Tutte le visite; Alla W004; Inclusione e W012
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Korea, Republic of
    Mexico
    Russian Federation
    Argentina
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial 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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 700
    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)
    nd
    nd
    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 Decision2015-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
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