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    EudraCT Number:2020-000238-16
    Sponsor's Protocol Code Number:APD791-202
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000238-16
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A blinded study to assess the safety, tolerability and effect of Temanogrel on Microvascular Obstruction in subjects undergoing Percutaneous Coronary Intervention (PCI).
    A.4.1Sponsor's protocol code numberAPD791-202
    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 SponsorArena Pharmaceuticals, 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 supportArena Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMehreen Hai
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    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 nameTemanogrel
    D.3.2Product code APD791
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTemanogrel
    D.3.9.1CAS number 957466-27-2
    D.3.9.2Current sponsor codeAPD791
    D.3.9.3Other descriptive nameTemanogrel hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Microvascular Obstruction
    E.1.1.1Medical condition in easily understood language
    Microvascular Obstruction
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079682
    E.1.2Term Microvascular occlusion
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the effect of temanogrel on MVO following PCI
    E.2.2Secondary objectives of the trial
    1. To assess the effect of temanogrel on selected coronary physiology indices and angiographic measures following PCI
    2. To assess the effect of temanogrel on myocardial injury following PCI;
    3. To assess the pharmacokinetics (PK) of temanogrel and its active metabolites AR295980 (M1) and AR295981 (M2) in subjects undergoing PCI;
    4. To assess the safety and tolerability of temanogrel in subjects undergoing PCI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    APD791-202 Amendment 2.0, Substudy A-Phase 2 (SSA-P2), Site Specific Addendum 1.0:
    - The primary endpoint of Study APD791-202 is based on a quantitative assessment of the coronary microcirculation using index of microcirculatory resistance (IMR). IMR is based on thermodilution curves obtained in triplicate from rapid injections of room temperature saline in the coronary artery during hyperemia, which is induced by
    intravenous administration of adenosine.

    - The aim of this substudy is to investigate changes in R and MRR from Baseline (prior to percutaneous coronary intervention [PCI] and administration of study treatment) to Pre-PCI (following study treatment administration ie, post-drug but pre-PCI) and Post-PCI (following PCI). These assessments will be performed immediately following measurements of IMR at sites participating in this substudy using the same Coroventis software utilized in the parent APD791-202 study. It is anticipated this may provide assessment of the coronary
    microcirculation that is complementary to, but distinct from, IMR. Specifically, these measures may provide insight into the effect of temanogrel on microcirculation at resting conditions, which may not be apparent during adenosine-induced hyperemia utilized when performing IMR assessments, as well as providing an absolute assessment of microvascular resistance.
    E.3Principal inclusion criteria
    - Stable angina patients referred for elective percutaneous coronary intervention (PCI), or non-ST-elevation myocardial infarction (NSTEMI) and unstable angina (UA) patients undergoing PCI at least 12 hours after diagnosis for NSTEMI/UA. NSTEMI/UA patients are to be consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction Grade 3 on the diagnostic angiography prior to PCI
    - Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography prior to PCI. The lesion must be located in a ≥2.75 millimeter (mm) diameter coronary artery; the lesion must also be ≥18 mm long and require the use of one or more stents that in total must be ≥20 mm long. Acceptable lesions cannot be in the left main artery or in a vein or arterial graft, or be a chronic total occlusion or in-stent restenosis. Two or more sequential lesions may be treated in the same artery, as long as they are treated in the same session and at least one of the lesions meets inclusion criteria
    - Both men and women participants agree to use a highly effective method of birth control throughout the entire study period, from informed consent through the adverse event reporting period, if the possibility of conception exists
    E.4Principal exclusion criteria
    - Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure;
    - Any history of stroke, head injury, seizure, intracranial bleeding, or intracranial aneurysm;
    - Transient ischemic attack within the 6 months prior to Screening;
    - History of major trauma, major surgery, and/or clinically significant hemorrhage within the last 6 months of Screening;
    - NSTEMI/UA with subsequent cardiac troponin levels that are increasing (not stable or dropping) as shown by the 2 most recent measures after diagnosis of NSTEMI/UA and prior to randomization;
    - Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 6 months of Screening (eg, a patient with a NSTEMI because of a lesion in a diagonal may not be included if there is a history of anterior STEMI due to left anterior descending artery lesion that occurred within the last 6 months);
    - Known history of heart failure.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in IMR from Baseline to Post-PCI
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline, pre-PCI, post-PCI.
    E.5.2Secondary end point(s)
    1. Change from Baseline to Post-PCI for the following assessments:
    • Coronary physiology indices (coronary flow reserve [CFR], fractional flow reserve [FFR]),
    • Angiographic measures (corrected thrombolysis in myocardial infarction frame count [cTFC], TFG, thrombolysis in myocardial infarction myocardial perfusion grade [TMPG]),
    • Myocardial injury markers (creatine kinase [CK], creatine kinase-myocardial band [CK-MB], cTn);
    2. Incidence of Procedural Myocardial Injury;
    3. Observed Maximum Plasma Concentration (Cmax) of Temanogrel and its Metabolites;
    4. Safety and tolerability of temanogrel
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Baseline, pre-PCI, post-PCI.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 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.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    United States
    United Kingdom
    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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 99
    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)
    Patients will continue on standard of care.
    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 Decision2020-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-23
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