Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A multi-center, randomized, double-blind, 52-week study to assess the safety of QVA149 compared to QAB149 in patients with chronic obstructive pulmonary disease (COPD) who have moderate to severe airflow limitation Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2012-001998-93
    Trial protocol
    		 HU   FI   BG  
    Global end of trial date
    30 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2018
    First version publication date
    25 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    QVA149A2340
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01682863
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of QVA149 27.5/12.5 μg b.i.d. and QVA149 27.5/25 μg b.i.d. in terms of adverse event (AE) reporting rate in patients with COPD with moderate to severe airflow limitation during 52 weeks of treatment
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 27
    Country: Number of subjects enrolled
    Hungary: 96
    Country: Number of subjects enrolled
    Romania: 97
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    United States: 266
    Country: Number of subjects enrolled
    Bulgaria: 67
    Worldwide total number of subjects
    615
    EEA total number of subjects
    349
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    334
    From 65 to 84 years
    281
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were randomized to each treatment arm in 1:1:1 ratio.

    Pre-assignment
    Screening details
    		 Six hundred fifteen patients were randomized. One patient was randomized but did not receive treatment due to an adverse event. In the safety set, patients were analyzed according to the treatment received.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QVA149 27.5/12.5 ug bid
    Arm description
    		 QVA149
    Arm type
    		 Experimental

    Investigational medicinal product name
    indacaterol maleate-glycopyrronium bromide
    Investigational medicinal product code
    QVA149
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    27.5/12.5 ug bid

    Arm title
    		 QVA149 27.5/25 ug bid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    QVA149
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    27.5/25

    Arm title
    		 QAB149 75 ug od
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    QVA149
    Investigational medicinal product code
    QAB149
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhalation capsule

    Number of subjects in period 1
    		QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Started
    204
    204
    207
    Safety set
    204
    204
    206
    Randomized set
    204
    204
    207
    Full analysis set (FAS)
    204
    204
    206
    Completed
    177
    187
    183
    Not completed
    27
    17
    24
         Adverse event, serious fatal
    1
    3
    4
         Physician decision
    -
    -
    1
         Technical problems
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    2
         Protocol deviation
    1
    -
    1
         Lost to follow-up
    5
    1
    6
         Subject/guardian decision
    19
    12
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    QVA149 27.5/12.5 ug bid
    Reporting group description
    		 QVA149

    Reporting group title
    QVA149 27.5/25 ug bid
    Reporting group description
    		 -

    Reporting group title
    QAB149 75 ug od
    Reporting group description
    		 -

    Reporting group values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od Total
    Number of subjects
    		 204 204 207 615
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 113 104 117 334
        From 65-84 years
    		 91 100 90 281
        85 years and over
    		 0 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 64 ± 7.9 63.9 ± 8.5 62.8 ± 8.52 -
    Gender, Male/Female
    Units: Participants
        Female
    		 73 81 58 212
        Male
    		 131 123 149 403

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    QVA149 27.5/12.5 ug bid
    Reporting group description
    		 QVA149

    Reporting group title
    QVA149 27.5/25 ug bid
    Reporting group description
    		 -

    Reporting group title
    QAB149 75 ug od
    Reporting group description
    		 -

    Primary: Percent of patients with adverse events, serious adverse events, and death

    		 Close Top of page
    End point title
    		 Percent of patients with adverse events, serious adverse events, and death [1]
    End point description
    The overall rate of adverse events reported from initiation through 30 days post last dose. No statistical analysis was specified for this outcome measure.
    End point type
    Primary
    End point timeframe
    56 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was specified for this outcome measure.
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    204
    204
    206
    Units: percent
    number (not applicable)
        Patients with at least one SAEs
    12.7
    12.3
    11.7
        Patients with at least one AE
    68.1
    69.6
    67.5
        Death
    0.5
    1.5
    2.4
    No statistical analyses for this end point

    Secondary: Time to premature discontinuation of treatment

    		 Close Top of page
    End point title
    		 Time to premature discontinuation of treatment
    End point description
    Time is calculated at the end of the specified weeks by the Kaplan Meier method
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    204 [2]
    204 [3]
    206 [4]
    Units: Days
        median (confidence interval 95%)
    384 (384 to 99999)
    9999 (999 to 99999)
    9999 (999 to 99999)
    Notes
    [2] - 99999 value is a place holder in the Eudract sytem for which can't handle the term(NE)not estimable
    [3] - 99999 value is a place holder in the Eudract sytem for which can't handle the term(NE)not estimable
    [4] - 99999 value is a place holder in the Eudract sytem for which can't handle the term(NE)not estimable
    No statistical analyses for this end point

    Secondary: change from baseline in pre-dose trough FEV1

    		 Close Top of page
    End point title
    		 change from baseline in pre-dose trough FEV1
    End point description
    Pulmonary function assessments were performed using centralized spirometry according to ATS/ERS standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, airflow limitation severity and visit, treatment * visit interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    192
    196
    199
    Units: Liters
        least squares mean (standard error)
    0.116 ± 0.0169
    0.116 ± 0.0167
    0.037 ± 0.0169
    No statistical analyses for this end point

    Secondary: Change from baseline in FEV1 measurements at all post-baseline time points

    		 Close Top of page
    End point title
    		 Change from baseline in FEV1 measurements at all post-baseline time points
    End point description
    Pulmonary function assessments were performed using centralized spirometry according to ATS/ERS standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    200
    202
    202
    Units: Liters
    least squares mean (standard error)
        Day 1
    0.166 ± 0.0088
    0.178 ± 0.0088
    0.122 ± 0.0089
        Day 29
    0.257 ± 0.0152
    0.287 ± 0.0151
    0.173 ± 0.0151
        Day 57
    0.267 ± 0.0157
    0.302 ± 0.0155
    0.173 ± 0.0154
        Day 85
    0.269 ± 0.0164
    0.301 ± 0.0162
    0.17 ± 0.0162
        Day 141
    0.268 ± 0.0182
    0.288 ± 0.0179
    0.17 ± 0.0181
        Day 197
    0.229 ± 0.0178
    0.278 ± 0.0175
    0.157 ± 0.0177
        Day 253
    0.231 ± 0.0178
    0.24 ± 0.0175
    0.14 ± 0.0176
        Day 309
    0.199 ± 0.017
    0.222 ± 0.0169
    0.125 ± 0.017
        Day 365
    0.212 ± 0.0175
    0.221 ± 0.0173
    0.104 ± 0.0174
    No statistical analyses for this end point

    Secondary: Change from baseline in FVC measurement at all post-baseline time points

    		 Close Top of page
    End point title
    		 Change from baseline in FVC measurement at all post-baseline time points
    End point description
    Pulmonary function assessments were performed using centralized spirometry according to ATS/ERS standards.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    200
    202
    202
    Units: Liters
    least squares mean (standard error)
        Day 1
    0.316 ± 0.0201
    0.349 ± 0.02
    0.248 ± 0.0203
        Day 29
    0.375 ± 0.0274
    0.44 ± 0.0271
    0.28 ± 0.0272
        Day 57
    0.39 ± 0.0274
    0.439 ± 0.0271
    0.279 ± 0.0271
        Day 85
    0.388 ± 0.0287
    0.432 ± 0.0283
    0.268 ± 0.0284
        Day 141
    0.382 ± 0.0297
    0.403 ± 0.0292
    0.235 ± 0.0295
        Day 197
    0.313 ± 0.0288
    0.4 ± 0.0284
    0.22 ± 0.0288
        Day 253
    0.31 ± 0.0303
    0.365 ± 0.0298
    0.205 ± 0.0301
        Day 309
    0.272 ± 0.0284
    0.334 ± 0.0281
    0.185 ± 0.0285
        Day 365
    0.312 ± 0.0286
    0.323 ± 0.0282
    0.139 ± 0.0286
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing moderate or severe COPD exacerbation

    		 Close Top of page
    End point title
    		 Percentage of participants experiencing moderate or severe COPD exacerbation
    End point description
    Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    204
    204
    206
    Units: Percentage of participants
        number (not applicable)
    23.5
    24.9
    27
    No statistical analyses for this end point

    Secondary: Change from baseline in mean total daily symptom scores

    		 Close Top of page
    End point title
    		 Change from baseline in mean total daily symptom scores
    End point description
    The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. A negative change from baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    198
    199
    198
    Units: Score
        least squares mean (standard error)
    -1.57 ± 0.133
    -1.56 ± 0.133
    -1.31 ± 0.135
    No statistical analyses for this end point

    Secondary: Change from baseline in the daily number of puffs of rescue medication over the 52 week period

    		 Close Top of page
    End point title
    		 Change from baseline in the daily number of puffs of rescue medication over the 52 week period
    End point description
    Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 QVA149 27.5/12.5 ug bid QVA149 27.5/25 ug bid QAB149 75 ug od
    Number of subjects analysed
    198
    199
    198
    Units: Number of puffs
        least squares mean (standard error)
    -1.89 ± 0.164
    -1.62 ± 0.164
    -1.73 ± 0.166
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    QVA149 27.5/12.5 bid
    Reporting group description
    		 QVA149 27.5/12.5 bid

    Reporting group title
    QVA149 27.5/25 bid
    Reporting group description
    		 QVA149 27.5/25 bid

    Reporting group title
    QAB149 75 od
    Reporting group description
    		 QAB149 75 od

    Serious adverse events
    		 QVA149 27.5/12.5 bid QVA149 27.5/25 bid QAB149 75 od
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 204 (12.75%)
    25 / 204 (12.25%)
    24 / 206 (11.65%)
         number of deaths (all causes)
    1
    3
    5
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BONE CANCER
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    COLON CANCER
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    KAPOSI'S SARCOMA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LUNG NEOPLASM MALIGNANT
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    METASTASES TO LUNG
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    METASTASES TO PERITONEUM
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    METASTASES TO SPINE
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NON-SMALL CELL LUNG CANCER STAGE IV
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA OF LUNG
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    AORTIC DISSECTION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    HAEMATOMA
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    FACIAL PAIN
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    8 / 204 (3.92%)
    5 / 204 (2.45%)
    10 / 206 (4.85%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    HAEMOTHORAX
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY MASS
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    PANIC ATTACK
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    BRAIN HERNIATION
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SKULL FRACTURED BASE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    SUBDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    ASPLENIA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    2 / 204 (0.98%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    ANGINA UNSTABLE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK SECOND DEGREE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BRADYCARDIA
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    CARDIAC TAMPONADE
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    CARDIOGENIC SHOCK
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY OCCLUSION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SILENT MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    BRAIN OEDEMA
         subjects affected / exposed
    0 / 204 (0.00%)
    2 / 204 (0.98%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HIATUS HERNIA
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA STRANGULATED
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    LARGE INTESTINE PERFORATION
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ORAL PAIN
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE ACUTE
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL IMPAIRMENT
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ARTHRITIS INFECTIVE
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BRONCHOPNEUMONIA
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ERYSIPELAS
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    H1N1 INFLUENZA
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 204 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    MENINGITIS
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    4 / 204 (1.96%)
    1 / 204 (0.49%)
    2 / 206 (0.97%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS ACUTE
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SINUSITIS
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 204 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    2 / 204 (0.98%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPOGLYCAEMIA
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 204 (0.00%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QVA149 27.5/12.5 bid QVA149 27.5/25 bid QAB149 75 od
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 204 (40.20%)
    86 / 204 (42.16%)
    88 / 206 (42.72%)
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    70 / 204 (34.31%)
    64 / 204 (31.37%)
    71 / 206 (34.47%)
         occurrences all number
    129
    154
    138
    COUGH
         subjects affected / exposed
    3 / 204 (1.47%)
    13 / 204 (6.37%)
    7 / 206 (3.40%)
         occurrences all number
    5
    16
    7
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    19 / 204 (9.31%)
    18 / 204 (8.82%)
    22 / 206 (10.68%)
         occurrences all number
    22
    21
    27
    UPPER RESPIRATORY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    10 / 204 (4.90%)
    14 / 204 (6.86%)
    13 / 206 (6.31%)
         occurrences all number
    11
    18
    16

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 15:16:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA