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    Summary
    EudraCT Number:2007-003648-31
    Sponsor's Protocol Code Number:M/273FO/22
    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:2008-02-21
    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 number2007-003648-31
    A.3Full title of the trial
    A phase IIa, randomised, multicentre, evaluator-blinded, 4-way crossover clinical trial to study the pharmacokinetics, safety, tolerability and effects on lung function of one day treatment of formoterol 12 µg qd delivered by 2 different dry powder inhalers (Aerolizer® and Almirall Inhaler), of the Fixed Dose Combination formoterol 12 µg + Aclidinium bromide 200 µg qd delivered by Almirall Inhaler, and of formoterol 12 µg bid delivered by Aerolizer®, in moderate to severe Chronic Obstructive Pulmonary Disease Patients.
    A.4.1Sponsor's protocol code numberM/273FO/22
    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 SponsorLaboratorios Almirall, S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.1.1.1Trade name Foradil® Aerolizer® 12 µg inhalation powder, hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmacéutica, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameForadil Aerolizer 12mcg inhalation powder, hard capsule
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNFormoterol fumarate dihydrate
    D.3.9.1CAS number 73573-87-2
    D.3.9.3Other descriptive nameFormoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 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 nameFormoterol Fumarate dihydrate 12mcg inhalation Powder
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFormoterol fumarate dihydrate
    D.3.9.1CAS number 73573-87-2
    D.3.9.3Other descriptive nameFormoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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: 3
    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 nameAclidinium bromide /formoterol fumarate dihydrated 200mcg/12mcg inhalation powder
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFormoterol
    D.3.9.1CAS number 73573-87-2
    D.3.9.3Other descriptive nameFormoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAclidinium bromide
    D.3.9.1CAS number 320345-99-1
    D.3.9.2Current sponsor codeLAS34273
    D.3.9.3Other descriptive nameAclidinium bromide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    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
    Twenty-four moderate to severe COPD patients will be included in the study.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess, in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients, the pharmacokinetics of:

    a) Formoterol 12 µg delivered by Foradil® via Aerolizer® (AER), once a day (one puff) for one day.
    b) Formoterol 12 µg delivered by Foradil® via Aerolizer® (AER), twice a day (one puff twice a day) for one day.
    c) Formoterol 12 µg delivered by Almirall Inhaler (ALM), once a day (one puff) for one day.
    d) Fixed Dose Combination (FDC) of formoterol 12 µg + aclidinium bromide 200 µg delivered by Almirall Inhaler (ALM), once a day (one puff) for one day.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability and effects on lung function after one single day of therapy (qd or bid) of the above mentioned 4 treatments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult caucasian male and non-pregnant, non-lactating female patients aged between 40 and 80 years, both inclusive, with stable moderate to severe COPD. Women of childbearing potential are allowed to enter the trial ONLY if they use a medically approved (mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test in serum at screening.


    2. Clinical diagnosis of moderate to severe COPD (stages II and III according to the 2006 GOLD classification), in stable conditions (no COPD exacerbation within the previous 6 weeks).


    3. Screening FEV1 value of 30 =< FEV1 < 80% of the predicted normal value (i.e, 100 x observed post-salbutamol FEV1 / predicted FEV1), measured between 30-45 minutes post-inhalation of 400 mcg of salbutamol.


    Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 1993).

    4. Post-salbutamol FEV1 / FVC < 70% at screening.


    5. Presence of COPD symptoms and FEV1 values at the time of randomisation remaining stable compared to Screening Visit, according to the investigators criteria.


    6. Current or ex-smokers with a 10 pack-yrs smoking history.


    Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarretes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarretes per day / 20 cigarretes per pack = 2; 2 x 10 years of smoking = 20 pack-year history).

    Patients smoking other tobacco types will be allowed if they meet the cigarette criterion as well.

    7. No clinically relevant abnormal physical findings or results of laboratory at screening examination, except those related with COPD.


    8. No clinically relevant values in the results of laboratory screening examination, except those related with COPD.


    9. No abnormalities in the screening 12-lead ECG, except those considered to be not clinically relevant, as determined by the investigator. QT and QTc [calculated according to Bazett’s formulae (QTc=QT [msec] / RR[sec]1/2), as indicated in the paper tracing generated by the equipment used to record the ECGs] lower than 500 milliseconds for males and females, and lower than or equal to 450 and 470 milliseconds for males and females, respectively, in the ECGs performed at screening and before each IMP administration.


    10. Eligibility and ability to participate in the trial and consent to do so in writing after the purpose and nature of the investigation have been explained
    E.4Principal exclusion criteria
    1. Presence of clinically significant diseases other than COPD, which may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it.

    2. Diagnosis of current or recent (less than 2 years) symptoms of asthma, allergic rhinitis or atopy.

    3. Presence of exercise-induced bronchospasm, pulmonary diseases or history of thoracic surgery.

    4. Presence of a respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to screening. Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial prior to randomisation.

    5. Hospitalisation for an acute exacerbation in the 3 months prior to screening.

    6. Eosinophil count 600 cells / mm3.

    7. Evidence of contraindicated use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

    8. Use of long-term oxygen therapy (≥ 15 hours/day).

    9. Presence of any clinically significant respiratory conditions defined as:
    ・ Known active tuberculosis.
    ・ History of interstitial lung or pulmonary thromboembolic disease.
    ・ Pulmonary resection during the past 12 months.
    ・ History of life-threatening COPD.
    ・ History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
    ・ Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial.

    10. Presence of any clinically significant cardiovascular conditions defined as:
    ・ Myocardial infarction during the last 6 months.
    ・ Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
    ・ Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
    ・ Arterial hypertension not sufficiently controlled by antihypertensive treatment (RR systolic > 170 mmHg; RR diastolic > 95 mmHg).
    ・ Clinically relevant tachycardia (heart rate>100 bpm) or bradycardia (heart rate < 45 bpm).

    11. Recent (less than 12 months) stroke.

    12. Unstable diabetes mellitus.

    13. History of untoward reactions to inhaled anticholinergics, 2-agonists, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).

    14. Intention to use any concomitant medication not permitted by this protocol or insufficient washout period for a particular prohibited medication (see section 10.3).

    15. Treatment with β2-antagonists (including eye drops).

    16. Treatment with drugs that may modify QT interval (non-potassium sparing diuretics, MAOIs, TCAs, SSRIs, antipsychotic agents, serotonin receptor agonists, macrolide antibiotics, fluoroquinolone antibiotics, anti-protozoal antibiotics and antihypertensive agents).

    17. Loss of more than 400 mL of blood within the previous 3 months, or more than 250 mL within the month before entering the trial.

    18. Positive test for hepatitis B surface antigen or HBc, HIV or hepatitis C antibodies. Patients vaccinated for Hepatitis B and not infected from the disease can take part in the trial.

    19. Inability to properly use a dry powder or pMDI inhaler device or to perform a spirometry.

    20. History of drug and/or alcohol abuse during the last 2 years, that may interfere with the trial activities compliance.

    21. Inability to communicate adequately with investigators and to comply with protocol requirements.

    22. Treatment with any Investigational Medicinal Product (IMP) within 6 weeks prior to screening or the equivalent time to 5 half-lives of the IMP, whichever is longer.

    23. Poor venous access.

    24. Non maintenance of regular day/night, waking/sleeping cycles (e.g., night shift workers will be excluded).

    25. Likelihood of not being co-operative, not taking the medication, not completing the Paper Diary Cards or not attending the clinic at the required times
    E.5 End points
    E.5.1Primary end point(s)
    - Relative bioavailability of formoterol 12 µg delivered by Almirall Inhaler (ALM) qd versus formoterol 12 µg delivered by Aerolizer (AER) qd.

    - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200µg ALM qd versus 12 µg ALM qd.

    - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200µg ALM qd versus 12 µg AER qd.

    - Relative formoterol bioavailability of 12 µg ALM qd versus 12 µg AER bid.

    - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200 µg ALM qd versus 12 µg AER bid.


    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 No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    overall tolerability
    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 No
    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
    evaluator-blinded
    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
    Formoterol Aerolizer and Formoterol Almirall Inhaler
    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 the trial is definied as last visit/last patient out.
    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 months3
    E.8.9.1In the Member State concerned days
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-21. Yes
    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 state16
    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)
    Medical care after the discharge from the study will be provided by the patient's family practitioner.
    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 Decision2007-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-12
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