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    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-005066-37
    Sponsor's Protocol Code Number:AC-052-415
    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:2006-02-15
    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 number2005-005066-37
    A.3Full title of the trial
    COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study
    A.3.2Name or abbreviated title of the trial where available
    COMPASS-1
    A.4.1Sponsor's protocol code numberAC-052-415
    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 SponsorActelion Pharmaceuticals Ltd.
    B.1.3.4CountrySwitzerland
    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.2.1.1.1Trade name viagra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/178
    D.3 Description of the IMP
    D.3.1Product namesildenafil
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Film-coated 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 171599-83-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types:
    - Idiopathic
    - Familial
    - Associated with:
    Corrected congenital systemic-to-pulmonary shunts
    Drugs and toxins
    Patients are already on prescribed bosentan therapy for at least 12 weeks.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that a single dose of sildenafil 25 mg reduces pulmonary vascular resistance (PVR) in symptomatic stable patients with pulmonary arterial hypertension (PAH) already treated with bosentan 125 mg b.i.d. for at least 12 weeks.
    E.2.2Secondary objectives of the trial
    To assess the effect of a single dose of sildenafil 25 mg on

    1) total pulmonary resistance (TPR) and on

    2) N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) in symptomatic stable patients with PAH already treated with bosentan 125 mg b.i.d. for at least 12 weeks.

    3) To explore whether previous treatment with bosentan 125 mg b.i.d. for at least 12 weeks promotes vasoreactivity in patients who had been non-responders in a previous acute vasoreactivity test.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Signed informed consent

    2) Men or women >= 18 years of age

    3) Symptomatic PAH (WHO functional class II-III) of the following types:
    - Idiopathic
    - Familial
    - Associated with:
    Corrected congenital systemic-to-pulmonary shunts
    Drugs and toxins

    4) PAH diagnosed by right heart catheter within 24 months before enrollment, showing:
    - Mean pulmonary arterial pressure (mPAP) >= 25 mmHg
    - Pulmonary capillary wedge pressure (PCWP) <= 15 mmHg

    5) Documented non-responsiveness to acute vasoreactivity testing done within 24 months before enrollment but before start of bosentan therapy

    6) Treated with bosentan 125 mg b.i.d. as monotherapy for PAH for at least 12 weeks before enrollment

    7) Patient stable for at least 12 weeks before enrollment

    8) Right heart catheterization for 2-3 hours medically acceptable

    9) Pulmonary vascular resistance (PVR) at baseline 1 on the day of study performance >= 320 dyn.sec/cm5

    10) Women of childbearing potential must have a negative pre-treatment urine pregnancy test and use a reliable method of contraception during bosentan treatment and for at least 3 months after bosentan treatment termination.
    E.4Principal exclusion criteria
    1) Other types of PAH than listed above

    2) Epoprostenol treatment planned

    3) Suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary edema at high resolution computer tomography)

    4) Systolic blood pressure < 85 mmHg

    5) Body weight < 40 kg

    6) Hemoglobin <75% of the lower limit of the normal range

    7) AST and/or ALT > 3 times the upper limit of normal ranges

    8) Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C

    9) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements

    10) Conditions that prevent compliance with the protocol or adherence to therapy

    11) Pregnancy or breast-feeding

    12) Hypersensitivity to bosentan, sildenafil, or any of the excipients of their formulations

    13) Use of an investigational drug within 3 months before enrollment

    14) Treatment with PAH drugs, including endothelin receptor antagonists other than bosentan, PDE-5 inhibitors incl sildenafil, parenteral treatment (e.g., epoprostenol), other prostanoids, NO, or L-arginine within 3 months before enrollment

    15) Treatment with calcineurin inhibitors (e.g., cyclosporine A, tacrolimus, everolimus, sirolimus), fluconazole, ketoconazole, miconazole, amiodarone, ritonavir, glibenclamide (glyburide), alpha-blockers, nitrates, or calcium antagonists within 3 months before enrollment
    E.5 End points
    E.5.1Primary end point(s)
    PVR reduction from baseline 2 to 60 min after sildenafil administration expressed as percent change. This parameter is expected to be normally distributed with an SD of 20%. The reduction to be detected is 10%.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of trial is the last visit of the patient (28 days follow-up)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 44
    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)
    There is no plan for the provision of any additional care of the subjects once their participation in the trial has ended. Routine care will be provided.
    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 Decision2006-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
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