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    Summary
    EudraCT Number:2015-003895-65
    Sponsor's Protocol Code Number:DAL-301
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-04
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-003895-65
    A.3Full title of the trial
    A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in which the effects of dalcetrapib on heart and blood vessel risks will be compared against placebo in people who have specific genetic patterns and who have had a recent history of sudden, reduced blood flow to the heart: the dal-GenE trial
    A.3.2Name or abbreviated title of the trial where available
    dal-GenE trial
    A.4.1Sponsor's protocol code numberDAL-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02525939
    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 SponsorDalCor Pharma UK Ltd, Stockport, Swiss Branch Zug
    B.1.3.4CountrySwitzerland
    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 supportDalCor
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDalCor Pharma
    B.5.2Functional name of contact pointDonald M. Black
    B.5.3 Address:
    B.5.3.1Street Address42 Allison Road
    B.5.3.2Town/ cityPrinceton, New Jersey
    B.5.3.3Post code08540
    B.5.3.4CountryUnited States
    B.5.5Fax number+16096831606
    B.5.6E-mailDblack@dalcorpharma.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 nameDalcetrapib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDalcetrapib
    D.3.9.1CAS number 211513-37-0
    D.3.9.2Current sponsor codeRO4607381
    D.3.9.3Other descriptive nameDALCETRAPIB
    D.3.9.4EV Substance CodeSUB32549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    This study is investigating the cardiovascular morbidity and mortality (cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.
    E.1.1.1Medical condition in easily understood language
    This study is looking after cardiovascular disease, such as myocardial infarction (heart attack), in patients who have recently been hospitalized for this and have a particular genetic profile.
    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 PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality (cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.
    E.2.2Secondary objectives of the trial
    Time to first occurrence of:
    • The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization
    • The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for ACS (with ECG abnormalities), or unanticipated coronary revascularization
    • The composite of all cause death, resuscitated cardiac arrest, non-fatal MI, or non-fatal stroke
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with the appropriate genetic background and recently hospitalized for ACS (between 1 and 3 months following the index event), will be enrolled in this trial. ACS is defined as the occurrence of at least one of the following events:

    Myocardial Infarction (MI)

    Spontaneous MI

    A diagnosis of a qualifying MI event will be defined by a rise and/or fall of cardiac biomarkers (preferably cardiac troponin) with at least one determination greater than the 99th percentile upper reference limit (URL) plus at least one of the following described below:

    • Symptoms of myocardial ischemia, or
    • New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block, or
    • Development of pathological Q waves in the ECG, or
    • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, or
    • Identification of an intracoronary thrombus by angiography

    Procedure-Related MI after Percutaneous Coronary Intervention (PCI)

    A procedure-related MI after PCI is defined as an increase of cardiac troponin values with at least one determination greater than 5 times the 99th percentile URL in patients with normal baseline values (less than or equal to 99th percentile URL) or a rise of cardiac troponin values > 20% if the baseline values are elevated and are stable or falling; plus at least one of the following described below:

    • Symptoms suggestive of myocardial ischemia
    • New ischemic ECG changes
    • Imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality
    • Angiographic findings consistent with a procedural complication


    Hospitalization for ACS (ECG Abnormalities without Biomarkers):

    A diagnosis of a qualifying ACS event without increases in cardiac biomarkers will require admission to hospital or emergency room (exceeding 23 hrs) with symptoms presumed to be caused by myocardial ischemia with an accelerating tempo in the prior 48 hrs and/or prolonged (at least 20 min) rest chest discomfort and new ECG findings (or presumed new if no prior ECG available) as described below and at least one of the following:

    • at least 50% stenosis of an epicardial coronary artery
    • positive exercise or pharmacologic stress indicating reversible ischemia
    • presence of pathologic Q-waves on ECG

    Examples of New ECG findings include:
    • New or presumed new ST depression of at least 0.5mm in at least 2 contiguous leads or T wave inversion of at least 1mm in leads with predominant R wave or R/S >1 in at least 2 contiguous leads
    • New or presumed new ST elevation at the J point in ≥ 2 contiguous leads with the following cut-off points: ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new or presumed new left bundle branch block (LBBB)
    • New tall R wave of at least 40ms in V1 and/or V2 and R/S ≥ 1 in V1 with concordant positive T-wave in the absence of a conduction defect
    • New Q waves ≥ 30 ms wide and at least 1mm deep in any 2 leads of a contiguous lead grouping or Q wave >20ms or QS complex in leads V2 and V3 (these criteria also apply to silent MI detected during a routine follow-up visit)

    In addition, the following inclusion criteria apply:

    1. Both male and female subjects age 45 years and over at screening visit (V1)
    2. Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
    3. AA genotype at variant rs 1967309 in the ADCY9 gene as determined by cobas® ADCY9 Genotype CTA testing, conducted at a designated investigational testing site (ITS)
    4. Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
    5. Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L). Subjects with an LDL-C level ≥100 mg/dL (≥ 2.6 mmol/L) may be randomized if they cannot reach the target goal of less than 100 mg/dL despite lipid-lowering regimen, or are unable to tolerate lipid-lowering regimen.
    E.4Principal exclusion criteria
    1. Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
    2. Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one method of contracepton.
    3. New York Heart Association (NYHA) Class III or IV heart failure
    4. Last known hemoglobin <10 g/dL
    5. Index ACS event presumed due to uncontrolled hypertension
    6. Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg by the time of randomization despite anti-hypertensive therapy
    7. Last known serum triglyceride level > 500 mg/dL (> 5.65 mmol/L) as assessed within 6 months prior to randomization
    8. Last known hemoglobin A1c (HbA1c) >10% as assessed within 6 months prior to randomization
    9. Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
    10. Last known ALT or AST level > 3 times the upper limit of normal (ULN) or last known alkaline phosphatase level > 2 times the ULN as assessed within 6 months prior to randomization (excluding index event)
    11. History of persistent and unexplained creatine phosphokinase (CPK) levels > 3 times the ULN as assessed within 6 months prior to randomization (excluding index event)
    12. Last known serum creatinine > 2.2 mg/dL (195 μmol/l) as assessed within 6 months prior to randomization
    13. Previous exposure to anacetrapib or evacetrapib or documented allergic reaction to any CETP inhibitor
    14. History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 1 year prior to the screening
    15. Any clinically significant medical condition that according to the investigator could interfere with the conduct of the study
    16. Subjects whose life expectancy is shorter than 3 years
    17. Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient’s successful participation in the study
    18. Current alcohol or drug abuse or history thereof within 2 years prior to screening that would likely interfere with compliance, based on investigator assessment
    19. Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
    20. Subjects unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study
    21. Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the time from randomization to first occurrence of any component of the composite endpoint as adjudicated by the CEC. Components of the primary endpoint are:

    • Cardiovascular death
    • Resuscitated cardiac arrest
    • Non-fatal MI
    • Non-fatal stroke
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time 582 primary CEC adjudicated events occur in the combined treatment groups.
    E.5.2Secondary end point(s)
    Time to first occurrence of
    • The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure
    • The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization, or hospitalization for new or worsening heart failure
    • The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure
    • Fatal or non-fatal MI
    • All-cause death
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time 582 primary CEC adjudicated events occur in the combined treatment groups.
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA417
    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
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    New Zealand
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    United Arab Emirates
    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
    This is an event driven study and therefore the last visit will fall when approximately 582 primary events have occured.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months54
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months54
    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: 3000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2870
    F.4.2.2In the whole clinical trial 6000
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-23
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