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    Summary
    EudraCT Number:2011-000190-31
    Sponsor's Protocol Code Number:MEDCOR2011
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-08
    Trial results Removed from public view
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-000190-31
    A.3Full title of the trial
    Double-blind parallel placebo-controlled study to evaluate the effect of Molsidomine on the Endothelial Dysfunction in patients with stable angina pectoris undergoing a percutaneous CORonary intervention.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of clinical research intended to estimate the effect of Coruno ® molsidomine, on the dysfunction of the endothelium layer of cells which recover the inside of blood vessels and which plays a role in the dilation and the contraction of vessels as well as in the coagulation of the blood in patients suffering from stable angina pectoris and undergoing a percutaneous coronary intervention.
    A.3.2Name or abbreviated title of the trial where available
    MEDCOR2011
    A.4.1Sponsor's protocol code numberMEDCOR2011
    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 SponsorTherabel Pharmaceuticals Ltd
    B.1.3.4CountryIreland
    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 supportTherabel Pharmaceuticals Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSquarepoint-Pointcarre
    B.5.2Functional name of contact pointJacques Bruhwyler
    B.5.3 Address:
    B.5.3.1Street Address Rue Joseph Wauters 3
    B.5.3.2Town/ cityEcaussinnes
    B.5.3.3Post code7190
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3267444093
    B.5.5Fax number+3267444093
    B.5.6E-mailJ.Bruhwyler@scarlet.be
    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 Coruno®
    D.2.1.1.2Name of the Marketing Authorisation holderTherabel Pharma
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNMOLSIDOMINE
    D.3.9.1CAS number 25717-80-0
    D.3.9.4EV Substance CodeSUB09044MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 placeboTablet
    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
    Patients with stable angina undergoing elective PCI, used an add-on treatment on standard care therapy, molsidomine or placebo to improve the endothelial function (12 months treatment)
    E.1.1.1Medical condition in easily understood language
    Study versus placebo to estimate the effect of molsidomine on the endothelial dysfunction in patients presenting a stable angina pectoris and undergoing a percutaneous coronary intervention.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10011079
    E.1.2Term Coronary artery disease NOS
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    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 demonstrate in stable angina patients undergoing elective PCI the superiority of molsidomine, used as an add-on treatment on standard care therapy, over placebo on improving the endothelial function (Endoscore measured by RH-PAT) after 12 months of treatment.
    E.2.2Secondary objectives of the trial
    To estimate the effect of molsidomine and placebo on the augmentation index (an index of arterial stiffness) as measured by RH-PAT.
    To determine the impact of molsidomine on the following endothelial biomarkers:
     hs-CRP
     sICAM-1
     IL-8
     Myeloperoxidase (in terms of concentration and activity)
     Myeloperoxidase oxidized-LDL (MOx-LDL)
     Isoprostanes
     Microparticles from the endothelium, leukocytes and platelets
    To compare the rate of serious cardiovascular events (SCEs) in the two groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must satisfy ALL the following criteria at study entry (Visit 1 - Month -1):
    • Aged at least 18 years.
    • No treatment with molsidomine and/or long-acting nitrates (oral or patches) for more than 48 hours during the month preceding PCI and no treatment with these same drugs within 3 days before PCI.
    • Patients who the investigator believes that they and/or their Legally Acceptable Representative (LAR) can and will comply with the requirements of the protocol.
    • Written informed consent from the patient or from the LAR.
    All patients must satisfy the following criterion at randomisation (Visit 2 - Month 0):
    • Patients who underwent PCI for stable angina pectoris one month prior to the start of the study (30  7 days).
    • Patients presenting ED at Month 0 (Endoscore index <0.40) (Rubinshtein et al., 2009).
    E.4Principal exclusion criteria
    • Pre-menopausal women.
    • Patient with a clinically-active malignancy.
    • Known major renal insufficiency (creatinine 2.0 mg/ml) or known significant hepatic insufficiency (SGOT 2 times upper limit, total bilirubin 1.5 times upper limit).
    • History of psychological disorder, mental dysfunction, alcohol or drug abuse or any other factor which might interfere with the ability to cooperate in the study.
    • Participation in another clinical trial which has not yet reached its primary endpoint or with the same primary endpoint during the previous month.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject will be exposed to an investigational or a non-investigational product (vaccine, drug or device).
    • Hypersensitivity to molsidomine or to one of its excipients.
    • Peri-procedural infarction: CK-MB >3 times the upper reference limit (Thygesen et al., 2007).
    • Clinically significant abnormal pre-PCI CK-MB and troponin: any elevation above the upper reference limit (Thygesen et al., 2007).
    • Intolerance to galactose, deficiency in Lapp lactase or glucose-galactose malabsorption.
    • Left ventricular insufficiency (NYHA class III or IV) with an ejection fraction <35%.
    • Acute circulatory insufficiency (e.g. cardiogenic shock).
    E.5 End points
    E.5.1Primary end point(s)
    Change versus baseline in the Endoscore index in the two groups after one year of treatment (Month 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    E.5.2Secondary end point(s)
    • Change versus baseline in the Endoscore index in the two groups after six months of treatment (Month 6).
    • Change versus baseline in the augmentation index in the two groups after six and twelve months of treatment (Months 6 and 12).
    • Change versus baseline in the endothelial biomarkers (see Secondary objectives section) after six and twelve months of treatment (Months 6 and 12).
    • Frequency of serious cardiovascular events (SCEs) in the two groups after six and twelve months of treatment (Months 6 and 12).
    • Frequency of AEs and SAEs in the two groups after six and twelve months of treatment (Months 6 and 12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 and Month 12
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Effect on endothelial dysfunction in patient in stable angina pectoris
    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.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Phase A: The IDMC will advise the sponsor as to:
    - terminate the study, if the difference between the two groups is less than 10%.
    - Consider the study as completed if the primary endpoint has been achieved.
    Phase B: In all the other case, the study will proceed to Phase B.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A new ICF in emergency procedure is required for the patient 'ad-hoc PCI' with collection of the agreement of the patient in post-PCI. Patient will sign as soon as possible after ad-hoc PCI.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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)
    According to his opinion, the doctor decides on the treatment to be followed by his patient
    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 Decision2011-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-29
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