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    Summary
    EudraCT Number:2004-002216-28
    Sponsor's Protocol Code Number:A3711028
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-002216-28
    A.3Full title of the trial
    A multi-center, multinational, randomized, double-blind, placebo-controlled, proof of concept trial to assess the effects of a subject-optimized dose of UK-369,003 Modified Release on exercise capacity in subjects with pulmonary hypertension associated with chronic obstructive pulmonary disease.
    A.4.1Sponsor's protocol code numberA3711028
    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
    B.1.3.4Country
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNot Applicable - Name not assigned
    D.3.2Product code UK-369,003
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeUK-369,03
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 and 100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Pulmonary hypertension associated with chronic obstructive pulmonary disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of UK-369,003MR on exercise capacity as measured by change frombaseline in distance walked during the 6 Minute Walk Test (6MWT) after 12 weeks of treatment in subjects with PH associated with COPD.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effects of UK-369,003MR on health related quality of life as measured by the St George’s Respiratory Questionnaire.
    2. To evaluate the effects of UK-369,003MR on exertional dyspnea as measured by the Borg dyspnea score.
    3. To evaluate the safety and tolerability of UK-369,003MR in subjects with COPD associated PH.
    4. To evaluate the effects of UK-369,003MR on resting PaO2.
    5. To evaluate the effects of UK-369,003MR on the maximum oxygen desaturation during the 6MWT
    6. To evaluate the effects of UK-369,003MR on spirometry.
    7. To investigate the population pharmacokinetic parameters in these subjects.
    8. To investigate the effects of UK-369,003MR on time to clinical worsening.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subjects aged > 40 and < 75 years.
    2. Subjects who have COPD as defined by the GOLD criteria with the condition being stable for the preceding 6 weeks prior to the screening visit (no worsening of their COPD symptoms leading to change in class of medication used to treat their COPD or leading to hospital admissions or treatment with antibiotics for a presumed pulmonary infection).
    3. Subjects will have FEV1 < 80% predicted and FEV1/FVC<70% at screening post 400mcg salbutamol (or equivalent) delivered via a spacing device.
    4. Smokers or ex-smokers with a smoking history greater than 10 pack years (a pack year is equivalent to 20 cigarettes per day for 1 year equivalent).
    5. Subjects who have symptom limited exercise capacity with a 6 minute Walk distance of >100m and < 450m and who do not desaturate to a SaO2 <75% during or 5 minutes after this walk at screening visit.
    6. Subjects whose resting TTPG is ≥ 30 mmHg or mPAP measurement is > 20mmHg by right heart catheter during screening or within 3 months prior to the baseline visit (V1) (as long as these subjects with measurements before baseline visit (V1) have been stable with no worsening of their COPD that has resulted in changes in class of medication or treatment with antibiotics for a presumed pulmonary infection, or hospitalization since their catheter).
    7. Subjects who are capable of giving written informed consent to participate in the study.
    8. 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 with a history of asthma, allergic rhinitis or atopy
    2. Subjects with a history of other chronic pulmonary disease eg tuberculosis, lung cancer, cystic fibrosis, interstitial lung disease, known obstructive sleep apnoea or with significant restrictive lung disease (with a FEV1/FVC>70% post nebuliser) eg respiratory muscle weakness, or lung fibrosis
    3. Subjects who have had previous lung volume reduction surgery
    4. Subjects on continuous long term oxygen therapy for >15 hours per day
    5. Subjects with primary PH or PH associated with other lung disease other than COPD eg thromboembolism, HIV, congestive heart failure or schistosomiasis, sarcoid, tuberculosis or bronchiectasis, connective tissue disease etc
    6. Subjects who have had a new class of COPD or cardiopulmonary medication (eg diuretic, steroids) or change in class of these medications initiated within 6 weeks prior to entering the study at screening visit
    7. Subjects with a history of pulmonary embolism verified by ventilation/perfusion scan, angiogram or spiral chest CT scan within 6 months of randomization
    8. Subjects with congenital heart disease
    9. Subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation, or subjects with previous valvular surgery
    10. Subjects with a left ventricular ejection fraction (LVEF) less than 45% or LV shortening fraction <0.2 on echocardiogram at screening or within 3 months prior to study enrolment at screening visit
    11. Subjects with an episode of heart failure within the previous 30 days at screening visit
    12. Subjects with acute myocardial infarction or Cerebral Vascular Accident (CVA) within 3 months prior to study enrolment at screening visit
    13. Subjects with uncontrolled brady- or tachyarrhythmias (e.g., sinus arrest, complete heart block, atrial fibrillation or flutter, frequent runs of ventricular tachycardia); placement of dual chamber pacemakers and/or implantable defibrillators <60 days prior to screening
    14. Subjects whose 6-Minute Walk Test might be limited by conditions other than PH-associated dyspnea or fatigue, e.g., claudication from vascular insufficiency, significant arthritis or amputation of a lower limb without a suitable prosthesis
    15. Subjects with creatinine clearance <30 mL/min as determined by the Cockroft-Gault formula (Appendix 6 of the protocol) measured at screening visit
    16. Subjects with symptomatic postural hypotension
    17. Subjects who are obese with a BMI>35kg/m2
    18. Subjects with severe impairment of hepatic function, Child-Pugh Class C (Appendix 7 of the protocol), or portal PH
    19. Pregnant or lactating women or women of child bearing potential (i.e those who are not post-menopausal or surgically sterilised). Women who have undergone tubal ligation should be excluded.
    20. Subjects who have previously received chronic oral sildenafil or any other PDE5 inhibitor for any reason for a period exceeding 5 days
    21. Subjects who have taken sildenafil or any other PDE5 inhibitor in the 48 hours prior to screening and who are unwilling to cease taking this therapy for the duration of the study. Subjects who have received any PDE4 inhibitor in the 48 hours prior to screening (see exclusion 23)
    22. Subjects who are currently receiving any form of nitrates or nitric oxide donors (including nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, alpha blockers, [Subjects previously receiving any of these drugs must have stopped them for a period of at least 1 month prior to baseline visit]
    23. Subjects who have received any experimental drug within the past 3 months (prior to the first dosing day of the study).
    24. Subjects with a history of multiple clinically significant allergies
    25. Subjects who have evidence of any drug abuse including alcohol.
    26. Subjects who have donated blood during the previous month or intend to donate blood or blood products during the study or for one month following the completion of the study.
    27. Subjects with hereditary degenerative retinopathy e.g. retinitis pigmentosa
    28. Subjects who have untreated proliferative diabetic retinopathy
    29. Subjects with known allergies or intolerance to sildenafil or any other PDE5 inhibitor
    30. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in total distance walked during a 6MWT at week 12 of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 272
    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 Decision2005-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
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