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    Summary
    EudraCT Number:2009-012581-32
    Sponsor's Protocol Code Number:SB-480848/033
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012581-32
    A.3Full title of the trial
    A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
    (Short title: The Stabilization Of pLaques usIng Darapladib- Thrombolysis In Myocardial Infarction 52 [SOLID-TIMI 52] Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of darapladib in the prevention of heart attacks, stroke and death
    in patients who suffered a heart attack.
    A.3.2Name or abbreviated title of the trial where available
    SOLID-TIMI 52
    A.4.1Sponsor's protocol code numberSB-480848/033
    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 SponsorGlaxoSmithKline Research & Development, Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressGlaxoSmithKline, Iron Bridge Road, Stockley Park
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 4466
    B.5.5Fax number+44208990 4968
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namedarapladib
    D.3.2Product code SB-480848
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdarapladib
    D.3.9.2Current sponsor codeSB-480848
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    after recent Acute Coronary Syndrome (ACS)
    E.1.1.1Medical condition in easily understood language
    heart attacks caused by disease of the heart blood vessels
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 study is to evaluate clinical efficacy of long-term treatment with Darapladib Enteric Coated Tablets, 160 mg (oral once daily dose) as compared to placebo when added to standard of care in an ACS patient population on the incidence of first occurrence of the composite of MACE (i.e., CV death, non-fatal MI, non-fatal stroke).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the efficacy of darapladib on major and total coronary events (including CHD death, non-fatal MI, urgent and non-urgent coronary revascularization, or hospitalization for UA), individual components of MACE and all-cause mortality. Additional safety and efficacy parameters including relations to and changes of biomarkers of CV risk, health economic outcomes, and AEs will also be evaluated.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Substudies:
    Primary objective is to establish a population PK model adequate to describe the time-course and variability of plasma darapladib concentrations following repeat dose administration of Darapladib Enteric Coat Tablets, 160 mg in patients with ACS.
    Secondary objective is to establish a population PK/PD model adequate to describe the relationship between plasma darapladib concentration and plasma Lp-PLA2 activity following repeat dosing of Darapladib Enteric Coat Tablets, 160 mg in patients with ACS.

    Pharmacogentic analysis substudy to explore the:
    Relationship between genetic variants and the PK and/or PD of darapladib or related drugs.
    Relationship between genetic variants and safety and/or tolerability of darapladib or related drugs.
    Relationship between genetic variants or genetically defined disease subtypes to clinical efficacy of darapladib and clinical study outcomes.
    E.3Principal inclusion criteria
    1. Signed written informed consent prior to beginning study-related procedures
    2. Male or female aged at least 18 years, inclusive, at randomization. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator and in accordance with local
    practice in relation to adequate contraception. In Taiwan, subjects must be aged at least 20 years, inclusive, at randomization.
    3. Hospitalisation for ACS (unstable angina, non-ST segment elevation MI, or ST segment elevation MI) ≤30 days prior to randomization:
    a. Unstable angina (UA) is defined as ischemic chest discomfort (or equivalent)
    that occurs at rest with at least 1 episode lasting ≥10 minutes and is accompanied
    by new or presumably new ST segment deviation [transient (<20 minutes)
    elevation ≥0.1mV or dynamic horizontal/down-sloping depression ≥0.05mV)] in
    at least 2 contiguous leads without diagnostic biochemical changes in cardiac
    enzymes (serum troponin I or T, or creatine kinase-MB).
    b. Non-ST segment elevation MI (NSTEMI) is defined as ischemic chest
    discomfort (or equivalent) that occurs at rest with at least 1 episode lasting ≥10
    minutes and is accompanied by a diagnostic elevation in cardiac biomarkers of
    myocardial injury (serum troponin I or T, or creatine kinase-MB ) above the upper
    limit of normal without persistent ST segment elevation.
    c. ST segment elevation MI (STEMI) is defined as prolonged symptoms of
    ischemic chest discomfort (or equivalent) at rest (with at least 1 episode lasting
    >20 min) and new or presumably new electrocardiographic changes (persistent ST
    segment elevation ≥0.1 mV in ≥2 contiguous precordial leads or ≥2 adjacent limb
    leads or new LBBB) that are accompanied by a diagnostic elevation in cardiac
    biomarkers (serum troponin I or T, or creatine kinase-MB) above the upper limit
    of normal.
    4. All subjects must also have at least one of the following additional predictors of
    cardiovascular risk:
    a. age ≥60 years at randomization.
    b. history of documented MI prior to qualifying ACS event.
    c. diabetes mellitus requiring pharmacotherapy.
    d. significant renal dysfunction (defined as estimated glomerular filtration rate
    [eGFR] ≥30 and ≤59 mL/min per 1.73 m2).
    e. polyvascular disease manifested in this ACS population as coexistent clinically diagnosed arterial disease in at least 1 peripheral arterial territory, defined as:
    • cerebrovascular disease defined as carotid artery disease or as prior ischemic
    stroke that occured >3 months prior to randomization.
    OR
    • peripheral arterial disease (PAD)
    5. The subject must be clinically stable for 24 hours prior to randomization (clinical
    stability is defined as the absence of chest pain, hemodynamic instability [e.g., hypotension, requirement for inotropic therapy], or significant arrhythmia [e.g., arrhythmia requiring treatment]).
    6. For subjects in whom a PCI is planned as part of management for the qualifying
    ACS event, the subjects should undergo PCI prior to randomization whenever
    possible.
    E.4Principal exclusion criteria
    1. Clinical or laboratory manifestations of ACS (e.g., chest pain, ECG changes or
    increase in cardiac enzymes) that is not believed to be thrombotic in origin or is
    believed to be secondary to other apparent illness (e.g., sepsis, profound anemia,
    tachycardia, hypertensive emergency or decompensated heart failure).
    2. Absence of obstructive coronary artery disease (i.e., at least one stenosis [>50%] in a major vessel, major branch or bypass graft) based on angiography, if
    performed, between the time of presentation with ACS and randomization.(NOTE: If all stenoses are successfully treated by PCI, the patient is still eligible.)
    3. Planned coronary artery bypass graft (CABG) surgery or CABG surgery performed
    following the qualifying event and prior to randomization.
    4. Cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones), unstable liver disease (defined by the presence of any of the following felt by the investigator to be related to liver disease and not to other disease processes: ascites, encephalopathy, coagulopathy, hypoalbuminemia,
    oesophageal or gastric varices, or persistent jaundice), or evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase >1.5 x upper limit of normal [ULN]; or alanine aminotransferase (ALT) >2.5 x ULN) or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
    5. Severe renal impairment (e.g., patients with an eGFR <30 mL/min/1.73 m2 or
    receiving chronic dialysis) or history of nephrectomy or kidney transplant (regardless
    of renal function).
    6. Current severe heart failure (New York Heart Association [NYHA] class III or IV).
    7. Poorly controlled hypertension despite lifestyle modifications and
    pharmacotherapy.
    8. Any life-threatening condition with life expectancy <2 years, other than vascular
    disease, that might prevent the subject from completing the study.
    9. Severe asthma that is poorly controlled on pharmacotherapy.
    10. Positive pregnancy test (all female subjects of childbearing potential must have a
    urine or serum β-human chorionic gonadotropin [hCG] pregnancy test performed
    within 7 days prior to randomization) or is known to be pregnant or lactating.
    11. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
    12. Alcohol or drug abuse within the past 6 months. Current mental condition
    (psychiatric disorder, senility or dementia), which may affect study compliance or
    prevent understanding of the aims, investigational procedures or possible
    consequences of the study.
    13. Current or planned chronic administration of strong oral or injectable cytochrome P- 450 isoenzyme 3A4 (CYP3A4) inhibitors.
    14. Subjects with 2 known birth parents of at least 50% Japanese, Chinese, or Korean ancestry (or if unknown, a reasonable likelihood of such ancestry) must have a blood sample collected for assessment of Lp-PLA2 activity by the central laboratory prior to randomization. Those with Lp-PLA2 activity ≤20.0nmol/min/mL will be excluded from participation in the study.
    15. Previous exposure to darapladib (SB-480848).
    16. Use of another investigational product within 30 days or 5 half-lives (whichever is
    the longer) preceding the first dose of darapladib or matching placebo.
    17. Currently in a study of an investigational device.
    18. Any other reason the investigator deems the subject to be unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to the first occurrence of any component of the composite of major adverse cardiovascular events (MACE: CV death, non-fatal MI,
    or non-fatal stroke) in an ACS population treated with Darapladib Enteric Coated
    Tablets, 160 mg compared with placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to the first occurrence
    E.5.2Secondary end point(s)
    The composite measure of major coronary events that include the first
    occurrence of CHD death, non-fatal MI or urgent coronary
    revascularization for myocardial
    ischemia in darapladib-treated subjects compared with placebo
    • The composite measure of total coronary events that include the first
    occurrence of CHD death, non-fatal MI, hospitalization for unstable
    angina, or any coronary revascularization procedure (excluding PCI
    planned prior to randomization but performed after randomization) in
    darapladib-treated subjects as compared with placebo.The individual
    components of MACE (CV death, MI [fatal and non-fatal], stroke
    [fatal and non-fatal]) in darapladib-treated subjects as compared with
    placebo.
    • The first occurrence of any component of the composite of all-cause
    mortality, nonfatal MI, or non-fatal stroke.
    • All cause mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    First Occurence
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned41
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA330
    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
    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
    The trial should end with the last subject's in-clinic follow-up visit .
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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.1.3Elderly (>=65 years) Yes
    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 state655
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4160
    F.4.2.2In the whole clinical trial 11500
    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)
    As per section 5.7 of the protocol, subjects may be treated as deemed appropriate by the investigator following the end of the treatment phase (or early withdrawal, whichever is earlier). Investigational product will not be available to subjects after the study treatment phase.
    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 Decision2010-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-06
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