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    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-002783-12
    Sponsor's Protocol Code Number:BAYq6256/16483
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-002783-12
    A.3Full title of the trial
    A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension
    No
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    No
    Offene und multizentrische Studie bei Patienten mit Lungenhochdruck zum Überkreuzvergleich (Cross-over) von Verträglichkeit und Blutspiegeln von Iloprost (Ventavis) nach Inhalation von Ventavis mit dem Fox-Vernebler und dem I-Neb-Vernebler
    A.3.2Name or abbreviated title of the trial where available
    Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb
    A.4.1Sponsor's protocol code numberBAYq6256/16483
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trial Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref: "EU CTR" Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    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 Ventavis 10
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 Yes
    D.2.5.1Orphan drug designation numberORPHA131352
    D.3 Description of the IMP
    D.3.1Product nameVentavis 10
    D.3.2Product code Bay Q 6256
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    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 INNILOPROST
    D.3.9.1CAS number 78919-13-8
    D.3.9.2Current sponsor codeBay q 6256
    D.3.9.4EV Substance CodeSUB08136MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Ilomedin 20 [20 µg / ml]
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA13370
    D.3 Description of the IMP
    D.3.1Product nameIlomedin 20
    D.3.2Product code Bay q 6256
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNILOPROST
    D.3.9.1CAS number 78919-13-8
    D.3.9.2Current sponsor codeBay q 6256
    D.3.9.4EV Substance CodeSUB08136MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks
    NO
    E.1.1.1Medical condition in easily understood language
    No
    Patienten mit Lungenbluthochdruck im Schweregrad WHO III, die seit mindestens 4 Wochen eine Inhalationstherapie mit Ventavis 10 durchführen
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10036727
    E.1.2Term Primary pulmonary hypertension
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess, in subjects with pulmonary arterial hypertension, the acute tolerability of 5 µg iloprost inhaled as Ventavis 20 µg/mL solution through a FOX nebulizer with that of 5 µg iloprost inhaled as Ventavis 10 µg/mL solution through the I Neb nebulizer.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare the pharmacokinetics of iloprost as administered by these two methods
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 18 years.
    2. Written informed consent given. [This consent must have been given before any study-specific procedures are conducted. A single informed consent form will cover both the main study, Parts 1–3, and the extension, Part 4.]
    3. Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
    4. Current inhalative therapy with 5 µg iloprost using the I Neb nebulizer.
    5. WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost.
    6. Hemodynamic diagnosis of PAH showing mean pulmonary arterial pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) < 15 mmHg and pulmonary vascular resistance (PVR) > 320 dyn•s•cm–5.
    7. Ability to understand and follow study-related instructions.
    8. If non-specific types of chronic treatment for PAH are being administered: Stable dosage of these for at least the 4 weeks up to screening.
    9. If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these for at least the 3 months up to screening.
    E.4Principal exclusion criteria
    Related to pulmonary disease / PAH
    1. PAH related to any etiology other than those specified in the inclusion criteria, especially pulmonary veno-occlusive disease (PVOD)
    2. Documented evidence of thromboembolic disease (probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest computed tomography (CT) scan within the 3 years before the screening visit
    3. Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease, COPD)
    4. Receipt of atrial septostomy within the six months before the screening visit
    Related to cardiovascular disease
    5. Severe coronary heart disease or unstable angina
    6. Myocardial infarction within the six months before the screening visit
    7. Decompensated cardiac failure if not under close medical supervision
    8. Severe arrhythmias
    9. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
    10. Cerebrovascular events (e.g. transient ischemic attack or stroke) within 3 months before Screening Visit
    11. Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
    12. Systemic hypotension with systolic blood pressure < 85 mmHg
    Related to other conditions
    13. Hypersensitivity to the active substance or to any of the excipients
    14. Conditions where the effects of Ventavis on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage)
    15. Hepatic impairment (such as acute hepatitis, chronic active hepatitis, or liver cirrhosis Child-Pugh B, C)
    16. Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL and/or the requirement for dialysis
    17. Clinically relevant bleeding disorder or active bleeding
    18. Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
    19. Clinically relevant abnormal conditions (including laboratory values) at Screening Visit that, in the opinion of the investigator, would compromise the evaluation of the study drug
    Related to prior and concomitant medication
    20. Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before Screening Visit
    21. Addition or dose change of non-specific type of chronic treatments for PAH such as calcium channel blockers, nitrates, digitalis, or diuretics within 4 weeks before Screening Visit
    22. Treatment with an investigational drug or device which has not received regulatory approval within 4 weeks before Screening Visit or during study
    23. Any kind of prostanoid other than those mentioned in inclusion criteria no. 9 within a period shorter than 5 half-lives before treatment
    Others
    24. Pregnant or breastfeeding women
    25. Woman of child-bearing potential does not agree to use an adequate method of contraception, i.e. a combination of two effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study
    26. Investigators, study staff, or their immediate families
    27. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis in this study is of safety.
    The primary safety variable is:
    – The proportion of patients with a meaningful maximum increase (i.e. 25%) in heart rate AND/OR a meaningful maximum decrease (i.e. 20%) in systolic blood pressure within the 30 minutes after the start of inhalation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 30 minutes after start of inhalation
    E.5.2Secondary end point(s)
    The secondary safety variables are:
    – Maximum change in systolic, diastolic and mean arterial blood pressure,
    – Maximum change in heart rate within the 30 minutes following inhalation,
    – Maximum change in oxygen saturation within the 30 minutes following inhalation.

    - Pharmacokinetics of Iloprost as administered by two inhalers (Fox and I-Neb)
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 2 hours after start of each inhalation
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pk profiles until 60 min following inhalation of Ventavis 10 and Iloprost 20µg/m will be established
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ventavis 10 or Ilomedin 20µg/ml will be administered with the I-Neb and the Fox nebulizer
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    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
    The end of the study as a whole will be the date when the last subject completed Visit 4 (30 day follow-up period). All subjects will be offered to enter a long term extension Phase of up to 30 months until approval and commercial availability of Ventavis 20 and the FOX nebulizer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 subjects may:
    - return to using Ventavis 10 with the I-Neb nebulizer as they did before prior to entering the study
    - continue the long term extension part with Iloprost 20µg/ml and the FOX nebulizer and thereafter return to using Ventavis 10 with the I-Neb nebulizer
    - continue the long term extension part with Iloprost 20µg/ml and the FOX nebulizer and thereafter, if market authorisation has been granted, continue with Iloprost 20µg/ml and the FOX nebulizer in clinical routine.
    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 Decision2013-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-29
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