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    The EU Clinical Trials Register currently displays   39818   clinical trials with a EudraCT protocol, of which   6535   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-020932-20
    Sponsor's Protocol Code Number:D4250C00001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-020932-20
    A.3Full title of the trial
    A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase
    IIa Study to assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo controlled trial investigating the safety and effectiveness of AZD4017 in patients with raised intra-ocular pressure
    A.4.1Sponsor's protocol code numberD4250C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstra Zeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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.3.1Product nameAZD4017
    D.3.2Product code AZD4017
    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.3.9.1CAS number 1024033-43-9
    D.3.9.2Current sponsor codeAZD4017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Raised Intra-Ocular Pressure or primary
    open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in
    dose for at least 30 days prior to screening.
    E.1.1.1Medical condition in easily understood language
    Raised pressure within the eye or glaucoma
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036719
    E.1.2Term Primary open angle glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10022809
    E.1.2Term Intraocular pressure raised
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP) not on anti-glaucoma medication or patients with raised IOP or primary open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in dose for at least 30 days prior to screening. The primary efficacy variable will be the percentage decrease in IOP compared with baseline after 28 days of treatment.
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of systemically administered AZD4017 with placebo, by evaluation of safety variables.
    • To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of AZD4017
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures.
    2. Non-diabetic males and females aged 18 to 80 years, inclusive.
    3. Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit;
    OR
    Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication.
    4. Must have a best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.6 logarithm of the minimum angle of resolution (logMAR [Snellen equivalent of 20/80]) or better in each eye.
    5. Must have a <5 mmHg difference in mean IOP between eyes at 9AM at Baseline (Visit 3).
    6. Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP.
    7. Placebo treatment for duration of the study must not be considered detrimental to the patient.
    8. Must be willing to discontinue soft contact lens wear from 7 days prior to Visit 3 until the completion of the final study visit or to discontinue hard contact lens wear from 1 month prior to Visit 3 until the completion of the final study visit.
    9. Must be able to understand the consent form and comply with study requirements.
    E.4Principal exclusion criteria
    Ocular Exclusion Criteria:
    - Have uncontrolled intra-ocular hypertension (>36 mmHg).
    - Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect). Patients with severe central field loss in either eye is defined as a sensitivity ≤10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
    - Have narrow anterior chamber angles in either eye judged potentially occludable if pupillary dilatation were to occur, evidence or history of acute or chronic angle closure, or is at risk for angle closure as evidenced by anterior chamber angle less than grade 2 according to Schaffer classification, as measured by gonioscopy.

    General Exclusion Criteria:
    - Women of child-bearing potential (WOCBP).
    - Have uncontrolled systemic hypertension
    (BP >150/90).
    - Are receiving systemic (including vaginal/rectal) or inhaled steroid treatment at the time of the screening visit (Visit 2).
    - Have any screening laboratory abnormality that, in the investigator’s judgement, is considered to be clinically significant.
    - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject’s ability to participate in the study.
    - Had a change in dose or initiation of systemic therapies (including herbal medications, vitamins, and nutrient supplements [eg, fish oil, and zinc]) that can substantially affect IOP or the study outcome, such as (but not limited to) alpha adrenergic agents, beta-adrenergic blockers, calcium channel blockers, carbonic anhydrase inhibitors, angiotensin-converting enzyme inhibitors or other antihypertensive medications within 30 days prior to the screening visit (Visit 2), or anticipates a change in such therapy during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage decrease from baseline in IOP at endpoint
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final visit assessment
    E.5.2Secondary end point(s)
    1 - Number of patients experiencing a clinically relevant decrease in IOP
    2 − Change from baseline to final visit in eye exams, IOP measurements, corneal thickness, clinical laboratory test results, and vital signs
    3 − Incidence of AEs, DAEs, SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Day 28
    2 - Throughout study participation
    3 - Throughout study participation
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Sweden
    United Kingdom
    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
    The end of the study is defined as ‘the last visit of the last patient undergoing the study’
    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 months0
    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 months0
    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.1.1.1In 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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 Decision2011-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-30
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