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    Summary
    EudraCT Number:2016-000629-38
    Sponsor's Protocol Code Number:ACT14656
    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:2017-06-21
    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 number2016-000629-38
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled parallel arm dose titration study to assess the effects of SAR407899 in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective percutaneous coronary intervention (PCI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose Titration Study to Assess the Effects of SAR407899 in Patients with Microvascular Angina and/or
    Persistent Stable Angina despite Angiographically Successful Elective Percutaneous Coronary Intervention (PCI)
    A.4.1Sponsor's protocol code numberACT14656
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1182-1709
    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 SponsorSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Aventis Denmark A/S
    B.5.2Functional name of contact pointClinical Study Unit
    B.5.3 Address:
    B.5.3.1Street AddressSlotsmarken 13
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4545167000
    B.5.5Fax number+4545167010
    B.5.6E-mailclinicaltrialsinfo_denmark@sanofi.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 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.3.2Product code SAR407899A
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRHO-KINASE INHIBITOR
    D.3.9.1CAS number 923262-96-8
    D.3.9.2Current sponsor codeSAR407899A
    D.3.9.4EV Substance CodeSUB91911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 2
    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.3.2Product code SAR407899A
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRHO-KINASE INHIBITOR
    D.3.9.1CAS number 923262-96-8
    D.3.9.2Current sponsor codeSAR407899
    D.3.9.4EV Substance CodeSUB91911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule, hard
    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
    Microvascular coronary artery disease
    E.1.1.1Medical condition in easily understood language
    Cardiovascular diseases
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072685
    E.1.2Term Microvascular coronary artery disease
    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 assess the effects of SAR407899 on coronary vasomotor function using the coronary flow reserve (CFR) in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective PCI.
    E.2.2Secondary objectives of the trial
    -To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire physical limitation domain (SAQ-PL) in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective PCI.
    -To assess the safety of SAR407899 in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective PCI with a focus on identified risks such as hypotension and orthostatic hypotension.
    -To assess SAR407899 plasma concentrations in microvascular angina patients and/or persistent stable angina despite angiographically successful elective PCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patient not at childbearing potential ≥18 year-old or legal age of majority.
    - Female patient if she has undergone sterilization at least 3 months earlier or is postmenopausal.
    - Post-menopausal status is defined by having no menses for 12 months without an alternative medical cause.
    - In females not treated with hormonal replacement therapy (HRT), menopausal status is confirmed by a high follicle stimulating hormone (FSH) level greater than 40 IU/L.
    - In females on HRT and whose menopausal status is in doubt (ie, in women aged less than 45 years), a highly effective contraception methods will be required. Contraception should be used during the whole study and for at least seven days corresponding to time needed to eliminate study treatment.
    - Symptomatic stable angina pectoris (typical or atypical symptoms with an average of at least once weekly episodes over the past month),
    - Patients with non-obstructive (<50% stenosis) coronary arteries or intermediate stenosis (between 50 and 70%) should have fractional flow reserve (FFR) >0.80 or instantaneous wave-free ratio (iFR) >0.89 on angiogram documented within the previous 24 months*. In patients with stenting, a minimum diameter stenosis of <10% is required.
    or
    Coronary computed tomography angiography (CCTA) with finding of non-obstructive coronary arteries within the past 24 months* in patients without previous elective percutaneous coronary intervention (PCI).
    *Note: in cases of clinically suspected progression of atherosclerosis as per the Investigator, a more Contemporary (i.e., 6 months) evidence should be provided.
    - Baseline global coronary flow reserve (CFR) (measured during the study) assessed by 13N-ammonia or 82rubidium positron emission tomography (PET) scan <2.0.
    E.4Principal exclusion criteria
    - Any use of nitrates (except short-acting nitrates) and/or dipyridamole and/or phosphodiesterase type 5 (PDE 5) inhibitors within one week prior to baseline PET scan or anticipated to be used during the study.
    - Esophageal dysmotility or esophagitis.
    - Patients with acute coronary syndrome (ACS) [myocardial infarction (MI) and/or unstable angina] in previous 3 months.
    - Unsuccessful or incomplete coronary revascularization with residual obstructive stenosis or coronary artery disease (CAD) progression in native vessels as documented on invasive coronary angiography (≥50% stenosis) within 24 months of enrollment.
    - Percutaneous coronary intervention performed at the time of an ACS (MI or unstable angina).
    - Recent elective PCI within the past 3 months.
    - Patients with history of coronary artery bypass grafting (CABG).
    - Recent (≤3 months) major surgery (ie, valvular surgery, surgery for congenital heart disease), stroke, transient ischemic attack (TIA), sustained ventricular arrhythmia, clinically significant structural heart disease (moderate-severe valvular disease, hypertrophic cardiomyopathy, congenital heart disease, pulmonary hypertension).
    -Regional local flow abnormal perfusion defects at baseline PET scan*.
    *Note: if Contemporary evidence with invasive coronary angiography or coronary computed tomography angiography (CCTA) demonstrates non-obstructive coronary arteries or if the regional local flow abnormal perfusion defect on PET scan is consistent with previous studies then patient qualifies for the study.
    - Patients with cardiac conduction abnormalities (second or third degree atrioventricular [AV] block, sick sinus syndrome, symptomatic bradycardia, sinus node disease).
    - History of known carotid stenosis.
    - Contraindication or known hypersensitivity to adenosine or regadenoson.
    - Contraindication to aminophylline.
    - Contraindication to vasodilator stress PET scan.
    - Inability to discontinue treatment with methylxanthines treatment within 24 hours prior to PET scan.
    - Patient unable to read, understand and fill a questionnaire without any help (eg, partially visually impaired or blind).
    - Systolic Blood Pressure (SBP) <110 mmHg at baseline.
    - Presence at baseline of symptomatic orthostatic hypotension (SBP decrease of 20 mmHg or more at Minute 3 or Minute 5 between seated and standing position), or asymptomatic orthostatic hypotension with a decrease in SBP equal or greater than 30 mmHg at Minute 3 or Minute 5 when changing from the seated to the standing position.
    - Renal impairment [estimated glomerular filtration rate (eGFR) <50 milliliter (mL)/min/1.73m2 at screening and baseline].
    - Drug-induced liver injury related criteria:
    - Underlying hepatobiliary disease,
    - ALT >3 times the upper limit of normal (ULN).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 4 in uncorrected global CFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 4
    E.5.2Secondary end point(s)
    - Change from baseline to Week 4 on angina-induced physical limitation using SAQ-PL (disease-specific health-related quality of life)
    - Safety: Adverse events / treatment-emergent adverse events
    - Safety: Blood pressure and orthostatic blood pressure
    - Safety: Blood creatinine and cystatin C level
    - Pharmacokinetics: SAR407899 plasma concentration level
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From baseline to Week 4 : Change from baseline to Week 4 on angina-induced physical limitation using SAQ-PL (disease-specific health-related quality of life)
    - From Day 1 to Week 5 : Safety: Adverse events / treatment-emergent adverse events
    - From Day 1 to Week 5 : Safety: Blood pressure and orthostatic blood pressure
    - From Day 1 to Week 5 : Safety: Blood creatinine and cystatin C level
    - From Day 1 to Week 5 : Pharmacokinetics: SAR407899 plasma concentration level
    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 Yes
    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) 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Denmark
    Korea, Republic of
    Netherlands
    Sweden
    United States
    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
    LSLV
    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 months14
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days7
    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: 183
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 260
    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 Decision2017-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-23
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