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    Summary
    EudraCT Number:2005-001556-20
    Sponsor's Protocol Code Number:SB-480848/026
    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:2005-09-19
    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 number2005-001556-20
    A.3Full title of the trial
    SB-480848/026: An International, Multicenter, Randomized,
    Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated
    Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.

    A.4.1Sponsor's protocol code numberSB-480848/026
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSB-480848
    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.3.9.2Current 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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    SB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine, in an exploratory fashion, whether SB-480848 provides measurable benefit on intermediate CV endpoints (plasma hsCRP levels and the density of high strain spots in the non-intervened segment of coronary arteries characterized by palpography) following 52 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Biomarkers:
    • examine effects of SB-480848 on an array of circulating markers of inflammatory burden (IL-6, ICAM-1, sCD40L, MPO) and plaque instability (MMP-9) at 26 and 52 weeks of treatment.
    • examine effects of SB-480848 on plasma Lp-PLA2 activity and Lp-PLA2 target-related biomarkers (Lyso-PC, ox-NEFA and ox-LDL) at 26 and 52 weeks of treatment.
    Imaging:
    • determine the effects of SB-480848 on compositional and volumetric measures of coronary plaque and volumetric measures of vessel and lumen in non-intervened coronary segment measured by IVUS at 52 weeks of treatment.
    Endothelial function:
    • determine effects of SB-480848 on measures of endothelial function at 4, 13, 26 and 52 weeks of treatment.
    Safety:
    • assess safety and tolerability of SB-480848 over a 52 week treatment period.
    • examine effects of SB-480848 on the first occurrence of the components of the composite measure of MACE (Major Adverse Cardiovascular Events) over 12 months of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Signed written informed consent prior to beginning study-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study).
    2. Male or female aged 18 to 80 years of age at screening. Female subjects of
    childbearing potential must be willing to follow contraceptive measures (described in
    Appendix 3 of study protocol).
    3. Successful percutaneous coronary intervention (PCI) defined as placement of bare
    metal or drug eluting stent in the native coronary arteries
    or
    Uncomplicated diagnostic cardiac catheterization in subjects in whom no PCI is
    planned.
    Important: at least ≥50% of randomized subjects must present with ACS and
    evidence of myocardial necrosis (i.e., STEMI or NSTEMI). ACS is defined as a history
    of chest pain (or chest pain equivalent) lasting ≥ 20 minutes that occurred within 72 hours prior to the index hospitalisation and the presence of elevated concentrations of cardiac biomarkers (troponins). Pre-catheterization Troponin assessed by the local laboratory and determined to be >99th percentile of the values for a reference control group will be used to qualify as evidence of myocardial necrosis. The ACS or non-ACS status of patients indicated on the CRF will be used for the purpose of stratification in the study analyses.
    4. Baseline IVUS of the non-intervened coronary arterial segment recorded according
    to protocol-mandated criteria that contains a lesion with less than 50% stenosis by
    visual inspection on angiography (refer to IBIS-2 Study Manual: – Imaging Procedures and Measurements [Core Imaging Laboratory, 2005])
    5. Must be receiving at least one oral antiplatelet agent (e.g., aspirin, clopidogrel) at
    time of randomization.
    E.4Principal exclusion criteria
    Clinical and laboratory exclusion criteria:
    1. Evidence of clinical instability or new abnormal clinical laboratory findings post-PCI
    or post cardiac catheterization but prior to randomization that in opinion of the
    investigator makes the subject unsuitable for the study.
    2. History of CABG surgery.
    3. Planned cardiac surgery (e.g., CABG, valve repair or replacement) or planned major
    non-cardiac surgery within the study period.
    4. Stroke or resuscitated cardiac arrest in the past 6 months.
    5. QTc interval >440msec (males) or >450msec (females) at Screening
    6. History of chronic viral hepatitis (including hepatitis B surface antigen or hepatitis C
    antibody) or other chronic hepatic disorder. ALT or AST >2.5 x upper limit of normal or alkaline phosphatase or total bilirubin >1.5 x upper limit of normal at Screening. Note: isolated AST elevation in patients with acute myocardial infarction is not considered an exclusion criteria from the study participation.
    7. Renal impairment with serum creatinine >2.0 mg/dL (177umol/L) or calculated creatinine clearance <40 mL/min/1.73 m2 at Screening (based on MDRD Study equation [Levey, 1999]), or history of kidney transplant, or history of contrast nephropathy.
    8. Current inadequately controlled hypertension (blood pressure >160 mmHg systolic
    and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication.
    9. Recent use (within < 1 month) or currently receiving transdermal, oral, inhaled, or
    injectable corticosteroids.
    10. Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screen.
    11. History of severe heart failure defined as NYHA class III or IV or known severe left ventricular (LV) dysfunction (ejection fraction [EF]<30%) regardless of symptomatic status.
    12. History of adult asthma manifested by bronchospasm in the past 6 months, or
    currently taking regular anti-asthmatic medication(s).
    13. History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
    14. History of malignancy within the past 5 years, other than non-melanoma skin cancer.
    15. Current life-threatening condition other than vascular disease (e.g., very severe
    chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent
    a subject from completing the study.
    16. Alcohol or drug abuse within the past 6 months.
    17. Currently receiving oral or injectable potent CYP3A4 inhibitor(s). Subjects should be instructed to refrain from consumption of > 240mL daily of grapefruit-juice, which may inhibit CYP3A4.
    18. Previous exposure to SB-480848.
    19. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
    20. Pregnancy (defined as a positive pregnancy test by serum β-HCG) or lactation at
    Screening.
    21. Any subject the investigator deems unsuitable for the study (e.g., due to medical
    reasons, laboratory abnormalities, expected study medication noncompliance, or unwillingness or inability to comply with all study-related procedures).
    Anatomical exclusion criteria:
    22. Left main coronary artery stenosis >50% by visual inspection of coronary angiogram.
    23. Luminal diameter of the study vessel <2.5 mm by visual inspection of coronary
    angiogram.
    24. Severe tortuousity of the study vessel or any other relevant anatomical reasons (e.g., heavy calcifications) that the investigator deems inappropriate for IVUS study.
    E.5 End points
    E.5.1Primary end point(s)
    The study will have two co-primary endpoints in order to assess intermediate cardiovascular (CV) endpoints. They will include:
    - on-treatment differences between SB-480848 and placebo treated groups in circulating hsCRP levels following 52 weeks of treatment,
    and
    - the differences between SB-480848 and placebo treated groups in baseline-corrected density of Rotterdam Classification (ROC) grade III/IV strain spots/10mm within the region of interest (ROI) on IVUS-based palpography.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    As per protocol (see section 11.1).
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 300
    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 Decision2005-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-28
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