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    Summary
    EudraCT Number:2012-001398-97
    Sponsor's Protocol Code Number:20110118
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-14
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2012-001398-97
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease.
    FOURIER - Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events when Evolocumab (AMG 145) is used in combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease
    A.4.1Sponsor's protocol code number20110118
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 No
    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 nameEvolocumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEvolocumab
    D.3.9.2Current sponsor codeAMG 145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 No
    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 nameEvolocumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in cartridge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEvolocumab
    D.3.9.2Current sponsor codeAMG 145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in cartridge
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia
    E.1.1.1Medical condition in easily understood language
    Abnormal amounts of lipids in the blood
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in subjects with clinically evident cardiovascular disease.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the effect of treatment with evolocumab, compared with placebo, in subjects with clinically evident cardiovascular disease on the risk for:
    • cardiovascular death, myocardial infarction, or stroke
    • cardiovascular death
    • death by any cause
    • myocardial infartion
    • stroke
    • coronary revascularization
    • cardiovascular death or hospital admissions for worsening heart failure
    • fatal or non-fatal ischemic stroke or transient ischemic attack (TIA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4.1.1 Signed informed consent
    4.1.2 Male or female ≥ 40 to ≤ 85 years of age at signing of informed consent
    4.1.3 History of clinically evident cardiovascular disease as evidenced by ANY
    of the following:
    o diagnosis of myocardial infarction
    o diagnosis of non-hemorrhagic stroke (TIA does not qualify as
    stroke for inclusion)
    o symptomatic peripheral arterial disease (PAD), as evidenced
    by intermittent claudication with ankle-brachial index
    (ABI) < 0.85, or peripheral arterial revascularization
    procedure, or amputation due to atherosclerotic disease
    Note: the proportion of subjects with history of MI or nonhemorrhagic stroke > 5 years prior to screening will be determined by the sponsor
    4.1.4 At least 1 major risk factor or at least 2 minor risk factors below:
    Major Risk Factors (1 Required):
    o diabetes (type 1 or type 2)
    o age ≥ 65 years at randomization (and ≤ 85 years at time of
    informed consent)
    o MI or non-hemorrhagic stroke within 6 months of screening
    o additional diagnosis of myocardial infarction or non-hemorrhagic
    stroke excluding qualifying MI or non-hemorrhagic stroke (a)
    o current daily cigarette smoking
    o history of symptomatic PAD (intermittent claudication with ABI
    < 0.85, or peripheral arterial revascularization procedure, or
    amputation due to atherosclerotic disease) if eligible by MI or
    stroke history
    Minor Risk Factors (2 Required):
    o history of non-MI related coronary revascularization (a)
    o residual coronary artery disease with ≥ 40% stenosis in ≥ 2 large vessels
    o Most recent HDL-C < 40 mg/dL (1.0 mmol/L) for men
    and < 50 mg/dL (1.3 mmol/L) for women by central laboratory
    before randomization
    o Most recent hsCRP > 2.0 mg/L by central laboratory before
    randomization
    o Most recent LDL-C ≥ 130 mg/dL (3.4 mmol/L) or non-HDL-C
    ≥ 160 mg/dL (4.1 mmol/L) by central laboratory before
    randomization
    o metabolic syndrome (b)
    4.1.5 Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or non-HDL-C
    ≥ 100 mg/dL (≥ 2.6 mmol/L) by central laboratory during screening after ≥ 2 weeks of stable lipid lowering therapy per Appendix E
    4.1.6 Most recent fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory before randomization
    (a)Note: there is no time limit on additional qualifying medical history.
    (b)Definition: metabolic syndrome for this protocol is defined as ≥ 3 of the following (Alberti et al, 2009):
    • waist circumference > 102 cm (> 40 in.) for men and > 88 cm (> 35 in.) for women (Asian men, including Japanese > 90 cm; Asian women, except Japanese > 80 cm; Japanese women > 90 cm)
    • triglycerides ≥ 150 mg/dL (1.7 mmol/L) by central laboratory at final screening
    • HDL-C < 40 mg/dL (1.0 mmol/L) for men and < 50 mg/dL (1.3 mmol/L) for women by central laboratory at screening (Note: if the HDL-C level is one of criterion used to make the diagnosis of metabolic syndrome, it cannot be used as a separate risk factor)
    • systolic blood pressure (SBP) ≥ 130 mmHg or diastolic BP (DBP) ≥ 85 mmHg or hypertension treated with medication
    • fasting glucose ≥ 100 mg/dL (≥ 5.6 mmol/L) by central laboratory at final screening
    E.4Principal exclusion criteria
    4.2.1 Subject must not be randomized within 4 weeks of their most recent MI or stroke
    4.2.2 NYHA class III or IV, or last known left ventricular ejection fraction < 30%
    4.2.3 Known hemorrhagic stroke at any time
    4.2.4 Uncontrolled or recurrent ventricular tachycardia
    4.2.5 Planned or expected cardiac surgery or revascularization within 3 months after randomization
    4.2.6 Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg
    4.2.7 Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited
    4.2.8 Prior use of PCSK9 inhibition treatment other than evolocumab or use of evolocumab < 12 weeks prior to final lipid screening
    4.2.9 Untreated or inadequately treated hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, and free thyroxine (T4) levels that are outside normal range at final screening
    4.2.10 Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening
    4.2.11 Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by central laboratory analysis at final screening
    4.2.12 Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
    4.2.13 Personal or family history of hereditary muscular disorders
    4.2.14 LDL or plasma apheresis within 12 months prior to randomization
    4.2.15 Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
    4.2.16 CK > 5 times the ULN at final screening
    4.2.17 Known major active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
    4.2.18 Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years
    4.2.19 Subject has received drugs via a systemic route that have known major interactions with background statin therapy (see Appendix F) within 1 month prior to randomization or is likely to require such treatment during the study period
    4.2.20 Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
    4.2.21 Female subject who has either (1) not used acceptable method(s) of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment with IP and for an additional 15 weeks after the end of treatment with IP, unless the subject is sterilized or postmenopausal;
    menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ≥ 55 years old or 12 months
    of spontaneous and continuous amenorrhea with a follicle-stimulating hormone (FSH) level > 40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy
    • acceptable methods of preventing pregnancy include not having intercourse, birth control pills, injections, implants, or patches, intrauterine devices (IUDs), tubal ligation/occlusion, sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used
    with spermicide
    4.2.22 Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during treatment with IP and/ or within 15 weeks after the end of treatment with IP
    4.2.23 Known sensitivity to any of the active substances or their excipients to be administered during dosing
    4.2.24 Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject’s and investigator’s knowledge
    4.2.25 History or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the Investigator or Amgen physician, if consulted, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and hemorrhagic.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and hemorrhagic.)
    E.5.2Secondary end point(s)
    • time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
    • time to cardiovascular death
    • time to death by any cause
    • time to first myocardial infarction
    • time to first stroke
    • time to first coronary revascularization
    • time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first
    • time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first
    E.5.2.1Timepoint(s) of evaluation of this end point
    •time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
    •time to cardiovascular death
    •time to death by any cause
    •time to first myocardial infarction
    •time to first stroke
    •time to first coronary revascularization
    •time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first
    •time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarker development
    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 Yes
    E.8.1.7.1Other trial design description
    cardiovascular outcomes study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA550
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Iceland
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    Study is event driven based on 1630 MACE secondary endpoint events and will conclude when all subjects have attended an end of study visit and had appropriate safety follow-up (ie LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months56
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months56
    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: 15125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12375
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15746
    F.4.2.2In the whole clinical trial 27500
    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)
    Subjects may be eligible for continued treatment with Amgen IP by an extension protocol or as provided for by the local country’s regulatory mechanism. However, Amgen reserves the unilateral right, at its sole discretion, to determine whether to supply Amgen IP, and by what mechanism, after termination of the trial and before it is available commercially.
    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 Decision2012-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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