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    Summary
    EudraCT Number:2007-003621-24
    Sponsor's Protocol Code Number:MG-101-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-13
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-003621-24
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.
    A.4.1Sponsor's protocol code numberMG-101-01
    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 SponsorMondoGEN AG
    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 No
    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/3/03/173
    D.3 Description of the IMP
    D.3.1Product nameAviptadil
    D.3.2Product code VIP
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAviptadil
    D.3.9.1CAS number 40077-57-4
    D.3.9.3Other descriptive nameVIP
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 nebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065151
    E.1.2Term Idiopathic pulmonary arterial hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065152
    E.1.2Term Familial pulmonary arterial hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065150
    E.1.2Term Associated with pulmonary arterial hypertension
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the efficacy of a number of doses of Aviptadil acutely and after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety and tolerability of a number of doses of Aviptadil.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for admission to the study, the following criteria must be met:
    1. Male and female patients between 18 and 80 years of age with IPAH, familial PAH or PAH
    associated with CTD or RCHD.
    2. Patients with NYHA/WHO functional class II or III.
    3. Patients who have received stabilized therapy (i.e., therapy with [a] stable dose[s]) with an endothelin receptor antagonist approved for the treatment of PAH or a phosphodiesterase type 5 inhibitor approved for the treatment of PAH or a combination of both for at least 4 months prior to screening.
    4. Symptomatic PAH diagnosed as either IPAH, familial PAH or PAH associated with CTD or RCHD clinically stable for at least 1 month prior to the inclusion.
    5. An unencouraged 6-MWT of more than 200 meters but less than 550 meters at screening.
    6. Prior cardiac catheterization consistent with PAH, specifically mean pulmonary arterial pressure (PAPm) > 25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) ≤ 15 mmHg and PVR > 3 mmHg/L/min.
    7. Echocardiogram data acquired within 12 months prior to study drug administration that are consistent with PAH, specifically evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis.
    8. Chest radiograph or CT angiography consistent with the diagnosis of PAH generated within 12 months prior to study drug administration.
    9. Able to understand and willing to sign the Informed Consent Form.
    10. Results of pulmonary function tests (within the last 6 months) as follows: total lung capacity ≥ 60% predicted and forced expiratory volume in 1 second/forced vital capacity ≥ 50% predicted.
    E.4Principal exclusion criteria
    A patient may not enter the trial if any of the following criteria apply:
    1. Patients with NYHA/WHO functional class I or IV.
    2. Patients with PAH due to conditions other than IPAH, familial PAH or PAH associated with CTD or RCHD.
    3. Patients who are on therapy with prostanoids, endothelin receptor antagonists not approved for the treatment of PAH or phosphodiesterase type 5 inhibitors not approved for the treatment of PAH. Note: Calcium channel blockers can be given according to the judgement of the Investigator and are not limited to a certain substance or dose.
    4. Patients with Eisenmenger’s Syndrome (a condition where the patient has a septal defect of the heart or a persistent ductus arteriosus and where resulting pulmonary hypertension creates a reversal of the shunt).
    5. Patients who have a new type of chronic therapy (e.g. a different category of vasodilator, diuretic) for PAH added within the last month, except anticoagulants.
    6. Patients who have received therapy with an investigational drug within 3 months prior to the start of this study or who are scheduled to receive another investigational drug during the course of this study.
    7. Patients who have discontinued regular medication or who have changed dose or class of any medication within the last week, except anticoagulants or insulin.
    8. Patients with a concomitant disease that could interfere with their ability to perform the 6-MWT.
    9. Patients with an acute concomitant disease that could potentially complicate the assessment of PAH disease severity or response to therapeutic intervention.
    10. Patients with any illness other than PAH which might reduce life expectancy to less than 6 months.
    11. Patients incapable or unwilling to sign the informed consent.
    12. Patients pregnant and/or lactating. Females who plan to become pregnant during the study and females who are not using a highly effective method of birth control (failure rate less than 1% per year).
    13. Patients with any pre-existing disease known to cause pulmonary hypertension unless listed in the inclusion criteria. The following pre-existing diseases are exclusionary: obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension and HIV infection.
    14. Patients with a history of drug and/or alcohol abuse, as defined by the Investigator.
    15. Patients with PAH associated with repaired congenital heart disease, who underwent the corrective surgery within 12 months prior to screening.
    16. Patients taking prednisone at a dose higher than 20 mg/day.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the percentage change in PVR (peak PVR reduction compared to baseline PVR) after a single Aviptadil inhalation on Day 2, where baseline PVR is defined as the value measured when stability is reached prior to first investigational product inhalation at baseline (Base 2) and peak PVR is defined as the lowest value of PVR in post-baseline assessments (at 15,
    30, 45, 60, 90, 120, 150 or 180 minutes).
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Open-label follow up after chronic treatment phase
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 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
    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 years1
    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 years1
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 48
    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)
    Patients who completed this study, will be offered to participate in a phase III open-label study.
    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 Decision2008-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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