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    Summary
    EudraCT Number:2010-021414-32
    Sponsor's Protocol Code Number:A9541004
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-04
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-021414-32
    A.3Full title of the trial
    A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF PF-03049423 IN SUBJECTS WITH ISCHEMIC STROKE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF PF-03049423 IN SUBJECTS WITH ISCHEMIC STROKE
    A.4.1Sponsor's protocol code numberA9541004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01208233
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    B.1.3.4CountryUnited Kingdom
    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 supportPfizer Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinicalTrials.govCallCentre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.5Fax number13037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 nameN/A
    D.3.2Product code PF-03049423
    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 INNPF-03049423
    D.3.9.2Current sponsor codePF-03049423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.3.1Product nameN/A
    D.3.2Product code PF-03049423
    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 INNPF-03049423
    D.3.9.2Current sponsor codePF-03049423
    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 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
    ISCHEMIC STROKE
    E.1.1.1Medical condition in easily understood language
    ISCHEMIC STROKE
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective for Part 1: Safety Dose-Ranging Study
    To evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke following 14 days of dosing.

    Primary Objective for Part 2: Proof-of-Concept study
    To assess the efficacy of PF-03049423, relative to placebo, using the modified Rankin Score (mRS) in subjects with ischemic stroke at Day 90.
    E.2.2Secondary objectives of the trial
    Secondary Objective for Part 1: Safety Dose-Ranging Study
    To explore the PK-PD relationship of PF-03049423 and blood pressure (supine and standing) in ischemic stroke subjects following 14 days of dosing.

    Secondary Objective for Part 2: Proof-of-Concept study
    •To evaluate the safety and tolerability of PF-03049423, relative to placebo, in subjects with ischemic stroke.
    •To evaluate the effects of PF-03049423, relative to placebo, in subjects with ischemic stroke, on other clinically relevant measures of stroke recovery, specific upper extremity motor (Box and Blocks (B&B), hand grip strength test) and lower (gait velocity) motor endpoints as well as neurological outcomes (NIHSS) and functional outcomes (Barthel Index - BI) at Day 90.
    •To evaluate the pharmacokinetics of PF-03049423 in subjects with ischemic stroke.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women (women must be of non-child bearing potential), age 18-85 years, inclusive
    2. Supratentorial ischemic (non-hemorrhagic) infarct involving the cortex, as documented by neurological exam and Magnetic Resonance Imaging (MRI) scan (or Computed Tomography (CT) scan if MRI scan contraindicated). Strokes involving more than one area will be allowed as long as there is documented ischemic cortical involvement
    3. Baseline NIHSS of 6-20 inclusive
    4. New onset of upper extremity paresis or paralysis on the affected side (NIHSS Item 5, score between 1 and 4 inclusive)
    5. Enrolled in the study so that initial dose of study drug is administered 24-72 hours from stroke onset (time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when subject was last seen or was self-reported to be normal)
    6. Able to receive study medication orally after stroke onset. If dysphagia precludes oral intake, the subject consents to placement of a nasogastric tube to receive study medication (NOTE: administration of study drug through a gastrostomy tube is allowed if the tube is positioned within the stomach)
    7. Adequate gastrointestinal function for oral drug absorption
    8. Expectation that the subject will remain as an in-patient for at least the first 7 days of dosing (eg, acute care, rehabilitation, long-term care facility or nursing home)
    9. Subjects must participate in a rehabilitation program. Reasonable expectation that the subject will receive the full course of post-stroke rehabilitation as per standard of care (to include physical, occupational, speech, and cognitive therapy as indicated), and to be available for subsequent follow-up visits
    10. Willing and reasonably able to participate in the evaluation process to the point of accurate assessment
    11. Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study
    12. Reasonable likelihood to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
    13. Subjects who have received thrombolytic therapy (within 4.5 hours or 6 hours post onset of acute ischemic stroke if given intravenously or intra-arterially, respectively) may be enrolled as long as the subject has been stable to improving post treatment and if 24 hr prior to enrollment an MRI or CT (if MRI contraindicated) post thrombolysis does not demonstrate any significant new findings. As a guideline, using ECASS criteria: PH II: dense blood clot(s) exceeding 30% of the infarct volume with significant space occupying effect would serve as an exclusion criteria
    14. Use of antiplatelet and/or anti-thrombotic agents is acceptable
    15. No previous stroke in the 90 days prior to enrollment (except index stroke). A previous stroke >90 days from the time of enrollment may be allowed if it is confirmed that there were no clinically significant deficits from prior stroke(s)(example: mRS 0-1) and the investigator, in consultation with the Sponsor has concluded that all other inclusion criteria have been met
    E.4Principal exclusion criteria
    1.Women of child-bearing potential are excluded even if contraception is being used. For definition of child-bearing potential, see Section 4.4.1 of the protocol. Serum FSH level must be obtained for women aged 40-60 who have experienced amenorrhea for at least 2 years.2.NIHSS item 5 score of 0 for the upper extremity that may be involved with the stroke.3.Impaired level of consciousness(NIHSS section 1a score ≥2 points).4.Stroke that is primarily hemorrhagic,or ischemic stroke that does not involve the supratentorial cortex.This includes-but is not limited to the following examples:subcortical, lacunar,cerebellar or brainstem stroke that do not involve the supratentorial cortex.5.Previous stroke unless>90 days and well recovered as defined by mRS 0-1.6.Significant cerebral edema,clinically significant hematoma,hemorrhagic transformation or presence of clinically significant midline shift with effacement that is likely to cause further clinical deterioration in the opinion of the investigator in consultation with the sponsor.7.Subjects expected to undergo carotid endarterectomy(CEA; intra- or extra cranial) or any other vascular,but not limited to carotid stenting procedures, or intracranial procedure during the 3 month study period;these procedures are acceptable if they are performed before enrolment and if the patient’s condition is stabilized 24 hours before randomization.8.Intracranial pathology other than cerebral infarction on any admission imaging tests(eg, Intracranial Hemorrhage or Subarachnoid Hemorrhage, Arteriovenous malformation, cerebral aneurysm, or cerebral neoplasm) that would preclude participation in this study.9.Known CADASIL or Moyamoya Disease.10.12-lead ECG demonstrating QTcF>450 msec or a QRS interval>120 msec at screening. If QTc exceeds 450msec or QRS exceeds 120msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility..11.Abnormal blood glucose thought to significantly contribute to the neurological deficit.12.Any medical condition that,in the opinion of the investigator,may preclude full participation in this clinical study
    13.Abnormally labile BP or uncontrolled hypertension that,in the opinion of the investigator,may preclude full participation in this clinical study.Uncontrolled hypertension is defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.14.Supine BP at baseline of either<100mmHg systolic or<70mmHg diastolic.15.Total body weight<90 lb(40.9 kg)
    16.Medications in any of the following categories
    •Nitrates(current or considered a potential for use during the study)
    •Alpha blockers.This includes but is not limited to the following medications: terazosin HCl,tamsulosin HCl,doxazosin mesylate,prazosin HCl or alfuzosin HCl
    •Strong CYP3A4 inhibitors.This includes but is not limited to the following medications:clarithromycin,itraconazole,ketoconazole,nefazodone,telithromycin and HIV protease inhibitors, including:atazanavir,indinavir,nelfinavir,ritonavir,saquinavir
    •Concomitant use of other PDE5i.This includes but is not limited to the following medications:sildenafil,tadalafil,vardenafil
    •Specific P-glycoprotein (Pgp) substrate:This includes but is not limited to the
    following medications:digoxin and digitoxin.
    17.Abnormal liver enzymes/hepatic function (Serum bilirubin >1.5 ULN; Alkaline phosphatase>2.5 ULN; AST or ALT>2.5 ULN)
    18.Abnormal renal function (Creatinine>2.0 ULN)
    19.Significant pulmonary disease (eg,COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma) such that full participation in rehabilitation would not be possible in the opinion of the investigator
    20.Subjects living in a nursing home or incapable of independent living prior to the stroke
    21.Subjects with a known medical history of severe hearing loss/deafness or nonarteritic NAION.22.Subjects with hereditary degenerative retinal disorders (eg, retinitis pigmentosa)23. Subjects with a history of or risk for priapism, sickle-cell disease, multiple myeloma and myeloprofilerative disorders(eg, myeloid leukemia, polycythemia, thrombocythemia) or serious skin reactions.24.Blood donation of approximately 1 pint (500mL) within 56 days prior to dosing and 14 days after the end of study.25.Known hypersensitivity to any PDE5i.26.Known left ventricular (LV) outlet obstruction.27.Known diagnosis of cancer, except for localized, non-invasive or metastatic cancers of any type that are stable, and not currently treated and not expected to influence life expectancy over the 6 months post screening.28.History of seizure disorder or current seizure disorder.29.Pre-existing and active major psychiatric or other chronic neurological disease that would unduly influence the assessments in the study
    This is a shortened list of the exclusion criteria, the protocol should be reviewed for the full list.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints for Part 1: Safety Dose-Ranging Study
    Safety Measurement/Parameters:
    •Safety and tolerability in all cohorts as assessed from baseline to Day 14 by an independent Data and Safety Monitoring Board (DSMB) using study data, including AEs and vital signs. Additional AE data will be collected including brain Magnetic Resonance Imaging (MRI), ECG, physical (including neurological) examination, National Institute for Health Stroke Scale (NIHSS) scores, laboratory tests (including hematology, blood chemistry, urinalysis) C-SSRS. Specific stopping rules for individuals and for each cohort are in Section 3.1 of the protocol

    Primary Endpoints for Part 2: Proof-of-Concept study
    •Proportion of subjects with Modified Rankin Scale (mRS) ≤2 at Day 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    E.5.2Secondary end point(s)
    Secondary Endpoints for Part 1: Safety Dose-Ranging Study:
    Plasma concentrations of PF-03049423

    Secondary Endpoints for Part 2: Proof-of-Concept study:
    Key Secondary Endpoints
    Box and Blocks, Hand Grip Strength Test at Day 90.
    Secondary Endpoints
    ▪Proportion of subjects with minimal disability (mRS 0-1) at Day 90.
    ▪Proportion of subjects with NIHSS (0-1) at Day 90.
    ▪NIHSS on Day 90.
    ▪Barthel Index (BI) at Day 90.
    ▪Proportion of subjects with BI ≥95 at Day 90.
    ▪Proportion of subjects with BI =100 at Day 90.
    ▪Domains of Interest: RBANS Coding Sub Test, RBANS Naming Sub Test, Line
    Cancellation, Recognition Memory Test at Day 90.
    ▪Gait Velocity at Day 90.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 90
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Bulgaria
    Canada
    France
    Germany
    Hungary
    Korea, Republic of
    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
    As per protocol
    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 months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 Yes
    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 legally acceptable representative is permitted to consent on behalf of the subject for the subjects participation in the trial
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    The study medication will not be available after the trial has completed and the expected standard of care will be applied accordingly


    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Canadian Stroke Consortium
    G.4.3.4Network Country Canada
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-11-05
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