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    Summary
    EudraCT Number:2008-002089-74
    Sponsor's Protocol Code Number:Matyus-2008/1
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-04-17
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-002089-74
    A.3Full title of the trial
    The investigation of the effect of dihydralazine (Depressan) on macular edema of type 2 diabetes patients and of inhibition of semicarbazide-sensitive amine oxidase (SSAO).
    A.3.2Name or abbreviated title of the trial where available
    Dihydralazine trial
    A.4.1Sponsor's protocol code numberMatyus-2008/1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSemmelweis University
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    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
    Macular edema in patients with type 2 diabetes.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012675
    E.1.2Term Diabetic macular retinopathy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The investigation of the effect of dihydralazine (Depressan) on macular edema in type 2 diabetes patients and the investigation of inhibition of semicarbazide-sensitive amine oxidase (SSAO).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    30 to 75 years old, both men and women patients with type two diabetes mellitus.
    Oral antidiabeticum or insulin is administered as treatment.
    Diabetes was diagnosed according to diagnostic criteria of the American Diabetes Association and World Health Organisation.
    HbA1c values were measured between 7 to 9 percent.
    Blood pressure values in the time of inclusion were measured two times in five minutes and did not exceeded the value of 170/100 Hgmm.
    In order to maintain the homogeneity of the group of patients during the time of randomization (within a 14 days period) the average thickness of the central retina (central retinal thickness - CRT) in the patients with diabetic macular edema measured by Optical Coherence Tomorgaphy (OCT) should be within 250-400 microns.
    E.4Principal exclusion criteria
    Patient under 30 years or over 75 years.
    HbA1c level above 9%.
    Allergy or oversensitivity to dihydralazine, hydralazine or any vehicles
    - lupus erythematodes disseminatus (including drug induced cases)
    - aorta dilatation
    - heart valve stenosis
    - hypertensive cardiomyopathy
    - decreased performance of the right heart due to high blood pressure in the small blood circle.
    Respiratory center depression.
    Intracranial pressure elevation.
    Progressed (severe) decrease in kidney or liver function
    - brain circulation disorders and its complications
    - patients with slow metabolism (“slow acetylators”)
    - coronary diseases
    - bradycardia.
    Known neoplastic or neurological disease (except diabetic neuropathy), pregnancy, chronic inflammatory disease (e.g. tuberculosis), endocrine disease (except treated hyperthyroidism).
    Chronic kidney disease in the previous history (serum albumin higher than 170 mmol/l)
    Blood pressure higher than 170/100 Hgmm (with antihypertensive treatment).
    Myocardial infarction in the previous 6 months or hospitalization due to any cardiac events, stroke, transient ischemic attack, acute congestive cardiac failure.
    Major abdominal, thoracic or intracranial surgical intervention in the previous 3 months or its possibility during the study period.
    Any condition preventing the assessment, photography or OCT examination of the fundus (e.g. cornea wounds, cataract, vitreous hemorrhage).
    Angle closure glaucoma or its suspicion, which contraindicates regular pupil dilation.
    Glaucoma not treated appropriately with eye drops.
    Retinal pathologies with major effect on the fundus except diabetic macular edema.
    Wet form of atrophic age-related macular degeneration.
    Epiretinal membranes or vitreomacular traction detected with OCT.
    Myopia greater than 8 dioptries.
    Retinal venous or arterial vascular circulatory disorders in previous history.
    Any other reason but diabetic retinopathy for macular edema or any pathology that might influence or interfere with OCT measurements of retinal thickness (e.g. taut posterior hyaloid or epiretinal membrane).
    Any other ophthalmic condition which, according to the examiner’s opinion, decreases the chance of, or does not allow the absorption of macular edema and would not allow the improvement of visual acuity even after the resolution of the edema (e.g.: foveal atrophy, pigment deviations, dense subfoveal hard exudates, extraretinal causes such as amblyopia).
    Patients whose central retinal thickness (CRT) can not be detected with +/- 10% SD accuracy with OCT even with repeated mapping.
    Incapability of visual fixation (for any reason).
    Visual acuity below 20/200.
    Any treatment for diabetic macular edema in the previous 3 months (e.g. focal or grid macular photocoagulation, intravitreal or peribulbar corticosteroids, use of anti-VEGF drugs, or any other treatment).
    Panretinal photocoagulation in the previous 3 months.
    Need of laser eye surgery within 6 weeks of enrollment or its necessity during the treatment.
    Proliferative diabetic retinopathy in the study eye except neovascularization less than one disk diameter in size without intravitreal hemorrhage.
    Ocular surgery performed less than three months prior to enrollment or its need during the study (cataract extraction, retinal detachment or any other intraocular surgery).
    Aphakic eye.
    Participation in any other scientific study 30 days before inclusion or during the study.
    Pregnancy or lactation. Women may only take part in the study in case they are on regular anticoncipient drug therapy, or have undergone hysterectomy or tube ligation. All women in reproductive age should have a pregnancy test performed before the enrollment in the study and also after the last visit.
    External ophthalmic infection such as conjunctivitis, severe blepharitis.
    Known fluorescein allergy or known sensitivity to dihydralazin.
    Consuming of alcohol is not recommended during the treatment.
    Treatment with the drug may interfere with work in transportation, machine operation or any work involving risk of danger. This applies mostly at the beginning of treatment, switching drugs and simultaneous consumption of alcohol. This fact should be drawn to attention to all participants of the study.
    In case of patients with lactose intolerance it should be considered that tablets contain 79 mg of lactose, and thus patients with known lactose intolerance must be excluded
    Depressan tablets can not be administered together with sedatives, narcotics, antidepressants and other antipsyhotics (MAO-inhibitors, narcoleptics) in the survey because they enhance the antihypertensive effect of Depressan. The effect of sedatives and narcotics may also be increased by the drug.
    A decrease of the effect of Depressan is observed with the simultaneous administration of sympathomymetics (such as ephedrine) and indometacine, therefore patients administering any sympathomymetics or indometacine must be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of the investigated drug can be judged by the change of SSAO concentration in serum and the level of improvement of clinical symptoms. Efficacy is calculated by statistical methods. A 20 percent decrease of macular edema is considered as clinically significant (expected value:=350+/-90μm), one-sided test, Power=80%, alha.=0.05.
    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 No
    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) 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    self-controlled
    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 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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=65 years) No
    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 state44
    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 Decision2008-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
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