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    Summary
    EudraCT Number:2010-021664-16
    Sponsor's Protocol Code Number:SVUH
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-06
    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 ConcernedIreland - HPRA
    A.2EudraCT number2010-021664-16
    A.3Full title of the trial
    The role of doxycycline in the management of diastolic dysfunction

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the effect of a medicine called doxycycline in people with evidence of "stiffening" of the heart muscle
    A.3.2Name or abbreviated title of the trial where available
    The role of doxycycline in the management of diastolic dysfunction
    A.4.1Sponsor's protocol code numberSVUH
    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 SponsorSolvotrin Innovations 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 supportSolvotrin Innovations Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSolvotrin Innovations
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address225 Western Gateway Building
    B.5.3.2Town/ cityWestern Road
    B.5.3.3Post codeCork
    B.5.3.4CountryIreland
    B.5.4Telephone number+35321 4205339
    B.5.5Fax number+353214205397
    B.5.6E-mailfionaryan@solvotrin.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 By-Mycin 50mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Therapeutics Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameDoxycycline
    D.3.2Product code NA
    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 INNDoxycycline Hyclate
    D.3.9.1CAS number 24390-14-5
    D.3.9.2Current sponsor codeNone
    D.3.9.3Other descriptive nameDOXYCYCLINE HYCLATE
    D.3.9.4EV Substance CodeSUB01830MIG
    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 Yes
    D.2.1.1.1Trade name Vibramycin 25mg/5ml suspension (60ml)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDoxycycline
    D.3.2Product code ST01
    D.3.4Pharmaceutical form Oral suspension
    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 INNDoxycycline monohydrate
    D.3.9.1CAS number 17086-28-1
    D.3.9.2Current sponsor codeNone
    D.3.9.3Other descriptive nameNone
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diastolic dysfunction
    E.1.1.1Medical condition in easily understood language
    Diastolic dysfunction otherwise known as ventricular stiffness, is characterized by reduced left ventricular distensibility, delayed relaxation and abnormal filling.

    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 PT
    E.1.2Classification code 10052337
    E.1.2Term Diastolic dysfunction
    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 investigate the impact of doxycyline on MMP-2, MMP-9 and other markers of collagen turnover in patients with severe diastolic dysfunction and hypertensive heart disease
    E.2.2Secondary objectives of the trial
    To assess the impact of doxycycline on Doppler-echocardiographic parameters of diastolic dysfunction.

    To determine whether the impact of doxycycline on markers of collagen turnover in the aforementioned patients is associated with cardiac structural and functional changes on cardiac MRI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Treated for hypertension > 6 months

    Doppler-echocardiographic evidence of severe diastolic dysfunction (see Echo Doppler investigation below)

    Clinically stable (on same treatment for > 1 month)

    Informed consent
    E.4Principal exclusion criteria
    1. Age < 18 years at the time of randomisation

    2. Tetracycline allergy

    3. Pre-menopausal women (defined as last menstrual period <12 months earlier) (ie postmenopausal women only will be eligible for enrolment. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.

    4. Prior documented LVEF <45% or qualitative moderate or severe LV systolic dysfunction

    5. Change in diuretics within 1 month or recent admission for acute decompensated heart failure/ cardiovascular event (eg ischemia) < 3 months

    6. Haemodynamically severe valvular heart disease

    7. Evidence of significant inflammatory disease, connective tissue disease, hepatic disease, metabolic bone disease which may alter parameters of collagen metabolism

    8. Hypertrophic, restrictive or constrictive cardiomyopathy

    9. Clinically significant pulmonary disease as evidenced by hospitalisations or use of oral corticosteroids for pulmonary decompensation within 12 months, or requirement for home O2 or significant fibrosis

    10. Severe anaemia (Haemoglobin <8.0g/dL)

    11. Severe renal dysfunction (GFR < 30 mL/min/1.73m2)

    The estimated GFR (eGFR) will be calculated by the following MDRD equation:

    eGFR (ml/min/1.73m2) = 186 (serum creatinine mg/dL)1.154 X (age)0.203 X (0.742 if subject is female) X (1.210 if subject is African American).

    12. Subjects with hepatic dysfunction (one or more LFTs greater than three times the upper limit of normal)

    13. Gastro-oesophageal reflux disease

    14. Recent trauma or surgery (<6 months)

    15. Malignancy

    16. Subjects with contraindications to MRI
    a. Hypersensitivity to gadolinium containing contrast agents
    b. Brain Aneurysm Clip
    c. Implanted neural stimulator
    d. Implanted cardiac pacemaker or defibrillator
    e. Cochlear implant
    f. Ocular foreign body (e.g. metal shavings)
    g. Other implanted medical devices: (e.g. Swan Ganz catheter)
    h. Insulin pump
    i. Metal shrapnel or bullet.


    17. Contraindications to doxycycline therapy:

    a. Use in subjects with hypersensitivity to tetracyclines
    b. Use during pregnancy or breast feeding
    c. Obstructive oesophageal disorders such as stricture or achalasia.

    18. Subjects on cyclosporin.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of this study is the difference in plasma levels of MMP-2 and MMP-9 and other markers of collagen turnover in patients with severe diastolic dysfunction and hypertensive heart disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Time 0), 2 weeks, 4 weeks, 6 months and 12 months
    E.5.2Secondary end point(s)
    To assess the impact of doxycycline on Doppler Echocardiography parameters of diastolic dysfunction.

    To determine whether the impact of doxycycline on markers of collagen turnover in the aforementioned patients is associated with cardiac structural and functional changes on cardiac MRI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (Time 0), six months and 12 months
    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 No
    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.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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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 undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1.2Preterm 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    Expected normal treatment
    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 Decision2010-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-25
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