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    Summary
    EudraCT Number:2008-005575-96
    Sponsor's Protocol Code Number:LPL100601
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-15
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-005575-96
    A.3Full title of the trial
    A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
    A.3.2Name or abbreviated title of the trial where available
    STABILITY (The STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY)
    A.4.1Sponsor's protocol code numberLPL100601
    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, 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 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 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) 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 No
    D.3.11.8Extractive medicinal product No
    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
    chronic Coronary Heart Disease (cCHD)
    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
    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 a chronic Coronary Heart Disease (CHD) patient population on the incidence of first occurrence of the composite of Major Adverse Cardiovascular Events (MACE) (cardiovascular death, non-fatal Myocardial Infarction (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 unstable angina), 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 adverse events (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
    There are several sub-studies (appendixes 8 -11 of protocol, same date and version as main protocol):
    - A substudy on the investigation of the effect of darapladib on rate of progression of albuminuria as assessed by change in urine Albumin:Creatinine Ratio (ACR) in subjects with diabetes mellitus.
    - A substudy on the effect of darapladib on systolic blood pressure as assessed by 24-hour ambulatory blood pressure monitoring.
    - A substudy on the effect of darapladib on rate of decline in cognitive function.
    - Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Substudies.
    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 at least 18 years, inclusive, at screening. 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 in accordance with local practice in relation to adequate contraception.
    3. Current treatment with statin therapy unless not indicated according to treatment guidelines or contraindicated in the opinion of the investigator.
    4. Chronic CHD documented by at least one of the following:
    a.prior MI (>1 month prior to randomization).
    b. prior coronary revascularization procedure [percutaneous coronary intervention (PCI) > 1 month prior to randomization or coronary artery bypass graft (CABG) >3 months prior to randomization].
    c. multivessel CHD involving major epicardial coronary arteries confirmed by coronary angiography at any time (without revascularization).
    AND
    5. At least one of the following additional predictors of CV risk [a through f]:
    a. age >60 years at randomization.
    b. diabetes mellitus requiring pharmacotherapy.
    c. HDL-C <40 mg/dL (1.03 mmol/L).
    d. smoker (defined as at least 5 cigarettes per day on average) or a previous smoker (defined as at least 5 cigarettes per day on average when smoking) who discontinued within the past 3 months.
    e. significant renal dysfunction (defined as estimated glomerular filtration rate [eGFR] ≥30 and </=59 mL/min per 1.73 m2 OR urine ACR ≥30 mg albumin/g creatinine).
    f. polyvascular disease manifested as coexistent clinically diagnosed arterial disease in at least 2 arterial territories, defined as:
    • chronic CHD and cerebrovascular disease defined as carotid artery disease or prior ischemic stroke >3 months.
    OR
    • chronic CHD and peripheral arterial disease (PAD).

    E.4Principal exclusion criteria
    1. Planned coronary revascularization (PCI or CABG) or any other major surgical procedure.
    2. Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) or evidence of abnormal liver function tests [total bilirubin or alkaline phosphatase >1.5 x upper limit of normal (ULN); or ALT or AST >2.5 x ULN] or other hepatic abnormalities that in the opinion of the Investigator would preclude the subject from participation in the study.
    3. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or history of nephrectomy or kidney transplant (regardless of renal function).
    4. Current severe heart failure (New York Heart Association class III or IV).
    5. Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy.
    6. Any life-threatening condition with life expectancy <2 years, other than vascular disease, that might prevent the subject from completing the study (e.g., very severe chronic airways disease, known human immunodeficiency virus [HIV] positive, or cancer in the past five years other than non-melanoma skin cancer).
    7. Severe asthma that is poorly controlled on pharmacotherapy.
    8. Positive pregnancy test (all female subjects of childbearing potential must have a urine B-human chorionic gonadotropin [hCG] pregnancy test performed at Screening and/or within 7 days prior to randomization) or is known to be pregnant or lactating.
    9. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
    10. Alcohol or drug abuse within the past 6 months, or 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.
    11. Current or planned chronic administration of strong oral or injectable cytochrome P-450 isoenzyme 3A4 (CYP3A4) inhibitors.
    12. Subjects with both parents of Japanese, Chinese, or Korean 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 </=10 nmol/min/mL will be excluded from participation in the study.
    13. Previous exposure to darapladib (SB-480848).
    14. 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.
    15. Currently in a study of an investigational device.
    16. 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 a chronic CHD population treated with darapladib enteric coated tablets, 160 mg compared with placebo.
    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 No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA265
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state425
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5850
    F.4.2.2In the whole clinical trial 15500
    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 treatement 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 Decision2009-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-12
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