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    Summary
    EudraCT Number:2018-003441-42
    Sponsor's Protocol Code Number:D169EC00001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-003441-42
    A.3Full title of the trial
    An International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DETERMINE-preserved – Dapagliflozin EffecT on ExeRcise capacity using a 6-MINutE walk test in patients with heart failure with preserved ejection fraction
    A.3.2Name or abbreviated title of the trial where available
    DETERMINE-preserved
    A.4.1Sponsor's protocol code numberD169EC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 Yes
    D.2.1.1.1Trade name Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDapagliflozin
    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 INNDAPAGLIFLOZIN PROPANEDIOL
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
    E.1.1.1Medical condition in easily understood language
    Heart Failure with preserved pump function to eject blood flow
    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 10076396
    E.1.2Term Heart failure with preserved ejection fraction
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether dapagliflozin is superior to placebo in patients with chronic heart failure with New York Heart Association (NYHA) Functional Class II-IV (range I-IV, higher class represents worse functional class) and preserved ejection fraction (LVEF>40%) in
    - reducing patient-reported HF symptoms
    - reducing patient-reported physical limitation
    - improving exercise capacity
    E.2.2Secondary objectives of the trial
    To determine whether dapagliflozin is superior to placebo in increasing time spent non-sedentary, evaluated in a subset of at least 100 patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed informed consent prior to any study specific procedures
    2. Male or female, aged ≥40 years
    3. Documented diagnosis of symptomatic HF (NYHA functional class II-IV), which has been present for at least 8 weeks, optimally treated with pharmacotherapy and/or device therapy with at least intermittent need for diuretic treatment.
    4. LVEF >40% and evidence of structural heart disease documented by the most recent echocardiogram, or cardiac magnetic resonance imaging within the last 12 months prior to enrolment.
    5. NT-proBNP ≥250 pg/mL at Visit 1 for patients without ongoing atrial fibrillation/flutter. If atrial fibrillation/flutter is present at Visit 1, NT-proBNP must be ≥500 pg/mL.
    6. Patients should receive background standard of care as described below:
    All patients will be treated according to locally recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation/flutter).
    7. 6MWD ≥100 metres and ≤425 metres at both the Enrolment and Randomisation.
    E.4Principal exclusion criteria
    1. Presence of any condition that precludes exercise testing.
    2. Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial.
    3. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
    4. Type 1 diabetes mellitus.
    5. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at visit 1, unstable or rapidly progressing renal disease at time of randomisation.
    6. Systolic BP <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2a/b.
    7. Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 (Enrolment) or at Visit 2a/b
    8. Current acute decompensated HF or hospitalisation due to decompensated HF <4 weeks prior to enrolment.
    9. Myocardial infarction, unstable angina, coronary revascularization ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment.
    10. Planned coronary revascularization, ablation of atrial fibrillation/flutter and/or valve
    repair/replacement.
    11. Stroke or transient ischemic attack within 12 weeks prior to enrolment.
    12. Probable alternative or concomitant diagnoses which could account for the patient's HF symptoms and signs.
    13. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
    14. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac resynchronisation therapy. Prior implantation of a ventricular assistance device or similar device, or implantation expected after randomization.
    15. HF due to any of the following: known infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease.
    16. A life expectancy of <2 years due to any non-cardiovascular condition, based on Investigator's clinical judgement.
    17. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin).
    18. Acute or chronic liver disease with severe impairment of liver function (eg, ascites, oesophageal varices, coagulopathy).
    19. Women of child-bearing potential not willing to use a medically accepted method of contraception considered reliable in the judgment of the Investigator OR who have a positive urine pregnancy test at randomisation OR who are breast-feeding.
    20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site).
    21. Previous randomisation in the present study.
    22. Participation in another clinical study with an IP or device during the last month prior to enrolment.
    23. Inability of the patient, in the opinion of the Investigator, to understand and/or comply with studwith study medications, procedures and/or follow-up (especially completing ePRO assessments) OR any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study. Therefore, patients who are unable to read (eg, are blind or illiterate) should be excluded from participating in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week16 (higher scores represent less HF symptom frequency and burden).
    - Change from baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week16 (higher scores represent less physical limitation due to HF)
    - Change from baseline in 6-minute walk distance (6MWD) at Week16 (larger distances represent better functional capacity).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at Week16.
    E.5.2Secondary end point(s)
    Change from baseline at the end of the study in the total time spent in light to vigorous physical activity, as assessed using a wearable activity monitor (accelerometer).
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline until the week starting at Week14.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 EEA34
    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
    Brazil
    Bulgaria
    Canada
    Denmark
    Italy
    Japan
    Korea, Democratic People's Republic of
    Slovakia
    South Africa
    Sweden
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the Last subject
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 500
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-09
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