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    Summary
    EudraCT Number:2011-002273-29
    Sponsor's Protocol Code Number:GS-US-259-0133
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-06
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2011-002273-29
    A.3Full title of the trial
    A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects with Chronic Stable Angina and Coronary Artery Disease with a History of Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of Ranolazine in Type 2 Diabetic Subjects with Chronic Stable Angina and Heart Disease
    A.3.2Name or abbreviated title of the trial where available
    TERISA
    A.4.1Sponsor's protocol code numberGS-US-259-0133
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointInternational Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401223897496
    B.5.5Fax number4401223897284
    B.5.6E-mailclinical.trials@gilead.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 Ranexa
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A
    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.3.4Pharmaceutical form Prolonged-release 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 INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Angina
    E.1.1.1Medical condition in easily understood language
    Angina
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10049194
    E.1.2Term Stable angina pectoris
    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
    To evaluate the efficacy of ranolazine compared to placebo on the average weekly angina frequency in subjects with a history of type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) and chronic stable angina who remain symptomatic despite treatment with 1 or 2 concomitant antianginal agent(s).
    E.2.2Secondary objectives of the trial
    a) To evaluate the efficacy of ranolazine compared to placebo on average weekly frequency of sublingual nitroglycerin (SL NTG) use
    b) To evaluate the efficacy of ranolazine compared to placebo on angina-free days
    c) To evaluate the efficacy of ranolazine compared to placebo on proportion of subjects achieving at least a 50% reduction in the average weekly angina frequency
    d) To evaluate the efficacy of ranolazine compared to placebo on health-related QoL
    e) To evaluate the safety and tolerability of ranolazine compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Males and females aged at least 18 years
    3. At least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
    4. Coronary artery disease (CAD) documented by one or more of the following:
    (i) Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries
    (ii) History of myocardial infarction documented by positive CK-MB enzymes, troponins, or ECG changes
    (iii) Cardiac imaging study or exercise treadmill test diagnostic for CAD
    5. Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the 4-week single-blind placebo run-in period. Allowed antianginals are the following: (i) beta-blocker (except sotalol), (ii) CCB (either dihydropyridine or non-dihydropyridine) (iv) LAN
    6. Documented history of T2DM
    7. Willing to maintain stable tobacco usage habits throughout the study
    8. Willing to maintain stable activity levels throughout the study
    9. Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.
    E.4Principal exclusion criteria
    1. NYHA Class III and IV
    2. Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
    3. Stroke or transient ischemic attack within 6 months prior to Screening
    4. QTc > 0.5 second
    5. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
    6. Systolic blood pressure < 100 mmHg
    7. Clinically significant hepatic impairment
    8. Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
    9. Females who have positive serum pregnancy test
    10. Females who are breastfeeding
    11. Participation in another investigational drug or device study within 1 month prior to Screening
    12. Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to initiating the 4-week single-blind, placebo run-in period.
    13. Current treatment with potent inhibitors of CYP3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
    14. Current treatment with CYP3A and Pgp inducers (eg, rifampicin/rifampin, carbamazepine, and St. John’s wort)
    15. Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
    16. Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin
    17. Current treatment with Class I or III antiarrhythmic medications
    18. History of illicit drug use or alcohol abuse within 1 year of Screening
    19. Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study
    E.5 End points
    E.5.1Primary end point(s)
    Average weekly angina frequency over the last 6 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8 or last visit.
    E.5.2Secondary end point(s)
    1. Average weekly frequency of SL NTG use over the last 6 weeks of treatment
    2. Angina-free days over the last 6 weeks of treatment
    3. Proportion of subjects achieving at least a 50% reduction in the average weekly angina frequency
    4. Change from baseline in the SF-36 Mental and Physical Component Scores
    5. Patient’s Global Impression of Change (PGIC) scale score
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 8 or last visit.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Belarus
    Bulgaria
    Canada
    Czech Republic
    Georgia
    Germany
    Israel
    Poland
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Slovenia
    Ukraine
    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 patient last visit
    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 months4
    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 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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 363
    F.4.2.2In the whole clinical trial 900
    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)
    Subjects should continue concomitant antianginal medications and should restart any antianginal medications discontinued during the screening period after completion of all study procedures under the care of their primary treating physician.
    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 Decision2011-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-24
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