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    Summary
    EudraCT Number:2007-001036-31
    Sponsor's Protocol Code Number:A8361011
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-04-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-001036-31
    A.3Full title of the trial
    A 2-COHORT, MULTI-CENTRE, RANDOMIZED, DOUBLE BLIND (3RD PARTY OPEN), PLACEBO CONTROLLED 4-WAY CROSSOVER STUDY TO ASSESS THE EFFICACY OF SINGLE ORAL DOSES OF PF-00446687 ON ERECTILE FUNCTION IN MEN SUFFERING FROM ERECTILE DYSFUNCTION, USING 100 MG SILDENAFIL AS A POSITIVE CONTROL.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberA8361011
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern/a
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent. UK. CT13 9NJ
    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 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.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 namePF-00446687
    D.3.2Product code PF-00446687
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 662281-92-3
    D.3.9.2Current sponsor codePF-00446687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 VIAGRA ® 100 mg film-coated tablets.
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd, Ramsgate Road, Samdwich. UK. CT13 9NJ
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    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 INNSILDENAFIL CITRATE
    D.3.9.1CAS number 171,599-83-0
    D.3.9.2Current sponsor codeUK-92,480
    D.3.9.3Other descriptive nameViagra®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for oral solution
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Male erectile dysfunction (MED).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052003
    E.1.2Term Erectile dysfunction NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy of single oral doses of PF-00446687 200 mg in improving penile erectile activity, utilizing the penile plethysmography (Rigiscan® Plus) technique, in males suffering from erectile dysfunction.
    E.2.2Secondary objectives of the trial
    To establish efficacy of lower doses of PF-00446687 in improving penile erectile activity and if possible, determine the dose response, in this population.

    To assess subjective assessment of sexual arousal and desire by means of questionnaire following single doses of PF-00446687.

    To determine the safety and toleration of PF-00446687 in this population.

    To assess PK after single doses of PF-00446687 and sildenafil in this population.

    To assess Agouti Related Protein (AgRP) levels in this population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male subjects aged 18-65 years.
    2. Subjects who have given written informed consent to participate in the study.
    3. Subjects must be in a heterosexual stable relationship for at least the last 6 months.
    4. Subjects with erectile dysfunction of at least six months duration prior to entering the study. Erectile dysfunction is defined as “the inability to attain and/or maintain penile erection sufficient for satisfactory performance”. [protocol ref 1]
    5. Subjects with moderate to severe (6-16) erectile dysfunction as classified on the International Index of Erectile Function (IIEF).
    6. Subjects who, in the opinion of the investigator, are known responders to PDE5i’s, such as subjects with a current or recent (within 6 months) history of successful PDE5i use.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
    E.4Principal exclusion criteria
    1. Subjects who are either known non-responders to, or unlikely to respond to treatment with either MC4 agonists or PDE5i’s. This includes subjects who are diabetic, subjects with significant neurological disease, spinal cord injury, multiple sclerosis, or previous pelvic surgery including radical and nerve sparing prostatectomy.
    2. Subjects with any clinically significant abnormality, following review of pre-study
    laboratory data and after a full physical examination.
    3. Subjects with a history of significant cardiac disease, particularly moderate or severe cardiac failure, unstable angina or recent myocardial infarction, stroke or life-threatening arrhythmia within the previous 6 months.
    4. Subjects with a history of syncope or cardiac conduction abnormality (including
    paroxysmal brady or tachyarrhythmias).
    5. Subjects who suffer from hypo- or hypertension (treated as well as untreated) or have a resting supine blood pressure below 90/50 mm Hg or above 170/110 or who show a postural drop in either systolic blood pressure of >20 mm Hg or diastolic blood pressure of >10 mm Hg at screening.
    6. Subjects who are currently receiving vasoactive medication, such as (but not limited to) α-blockers, β-blockers, calcium antagonists.
    7. Subjects who are receiving drugs known to inhibit CYP3A4, such as ketoconazole
    (systemic), erythromycin, cimetidine, clarithromycin, fluvoxamine, intraconazole
    (systemic), voriconazole, protease inhibitors.
    8. Subjects with any clinically significant haematological, renal or hepatic abnormality.
    9. Subjects with major psychiatric disorders and those who have received treatment for any major psychiatric disorder (eg, psychosis or hospitalization due to major depression) within the past 12 months.
    10. Subjects who have received any experimental (ie, non-approved) drug within the past four months (prior to the first dosing day of the study).
    11. Subjects who drink more than 21 units of alcohol per week. (1 unit = 285 mL of beer or 25 mL of spirits or 125 mL of wine).
    12. Subjects with a history of controlled substance abuse within the past 2 years.
    13. Subjects who, in the opinion of the principal investigator, have any medical or
    psychological condition or social circumstances which would impair their ability to
    participate reliably in the study, or who may increase the risk to themselves or others by participating.
    14. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.
    15. Subjects with a history of hypersensitivity to study drug and its excipients or known allergy to sildenafil and/or MC agonists.
    16. Subjects with other forms of sexual dysfunction (eg, retrograde ejaculation, an
    ejaculation, painful ejaculation, premature ejaculation, hypoactive sexual desire and
    inhibited or absent orgasm).
    17. Subjects with Peyrone’s disease.
    18. Subjects with evidence or history of seizure disorder, clinically significant
    haematological, renal, hepatic, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
    19. History of febrile illness within 5 days prior to the first dose.
    20. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy).
    21. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing and subjects intending to donate during the study.
    22. Subjects with a 12-lead ECG demonstrating QTc >450 msec at screening.
    Criteria specific to Sildenafil:
    23. Subjects who are prescribed and/or taking medication which is contraindicated or
    cautioned with concomitant intake of PDE5 inhibitors, such as nitrates or nitric oxide
    donors in any form (oral, sublingual, buccal, inhalational or aerosols), cimetidine,
    CYP3A4 inhibitors, such as erythromycin, ketoconazole and protease inhibitors.
    24. Subjects with retinitis pigmentosa.
    25. Subjects who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5i exposure.
    26. Subjects with congestive cardiac failure or coronary artery disease causing unstable angina, recent history of myocardial infarction or stroke.
    E.5 End points
    E.5.1Primary end point(s)
    Total duration of erections > 60% rigidity at the base of the penis and area under the rigidity response curve (AUC) of erectile activity for the duration of the post dose time sequences.
    Total duration of erections > 60% rigidity at the base of the penis and AUC for the duration of (VSS-1 + VSS-2).
    Total duration of erections > 60% rigidity at the base of the penis and AUC for the duration of (Neutral-1 + Neutral-2).
    Duration of erections > 60% rigidity at the base of the penis and AUC at defined time sequences.
    Time to onset of first erection of > 60% rigidity and a minimum of 5 minutes duration
    Assessment of sexual interest and ,mental arousal .
    Diary of sexual events
    Exploring the dose an/or response relationship of PF-00446687.
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    3rd party open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application (ie, Clinical Trial Application (CTA)) and ethics application in the Member State.

    End of Trial in all participating countries is defined as Last Subject Last Visit.
    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 months9
    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 months9
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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 Decision2007-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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