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    Clinical Trial Results:
    A 12-month, open-labelled, randomised, parallel-group, multi-centre, interventional trial to evaluate the efficacy and safety of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) therapy on height velocity (Ht-V) in patients with idiopathic short stature in Korea.

    Summary
    EudraCT number
    2015-002613-30
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    18 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jul 2017
    First version publication date
    02 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GH-3899
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01778023
    WHO universal trial number (UTN)
    U1111-1125-4790
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsværd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) therapy compared with untreated group assessed by height velocity after 6 months of treatment in patients with idiopathic short stature (ISS) in Korea.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996).
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    18 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    0
    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)
    51
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 10 sites in South Korea.

    Pre-assignment
    Screening details
    Not applicable

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group A: 12-month Growth Hormone Treatment
    Arm description
    For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
    Arm type
    Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Norditropin® Nordilet®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Somatropin (recombinant deoxyribonucleic acid [rDNA] origin) 0.469 mg per kg of body weight was injected subcutaneously (s.c.; under the skin) in the evening in 7 days per week using the Norditropin® Nordilet® pen.

    Arm title
    Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Arm description
    Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
    Arm type
    Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Norditropin® Nordilet®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Somatropin (rDNA origin) 0.469 mg per kg of body weight was injected s.c. in the evening in 7 days per week using the Norditropin® Nordilet® pen.

    Number of subjects in period 1
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Started
    36
    15
    Completed
    36
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A: 12-month Growth Hormone Treatment
    Reporting group description
    For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Reporting group title
    Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Reporting group description
    Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Reporting group values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment Total
    Number of subjects
    36 15 51
    Age Categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    36 15 51
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    6.3 ± 1.5 5.9 ± 1.2 -
    Gender Categorical
    Units: Subjects
        Female
    17 6 23
        Male
    19 9 28
    Height
    Units: cm
        arithmetic mean (standard deviation)
    107.7 ± 8.7 105.8 ± 7.5 -

    End points

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    End points reporting groups
    Reporting group title
    Group A: 12-month Growth Hormone Treatment
    Reporting group description
    For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Reporting group title
    Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Reporting group description
    Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Primary: Height velocity (Ht-V)

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    End point title
    Height velocity (Ht-V)
    End point description
    Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), Visit 4 (6 months ± 7 days) and Visit 6 (12 months ± 7 days ), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. The analysis was performed on the full analysis set (FAS), which included all randomised subjects in Group A, who received at least one dose of the trial product and all randomised subjects in Group B.
    End point type
    Primary
    End point timeframe
    After 6-month of treatment
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    32 [1]
    15
    Units: cm/year
        least squares mean (standard error)
    12.02 ± 0.29
    6.87 ± 0.43
    Notes
    [1] - Out of 36 exposed subjects, 4 subjects had missing values for height at baseline visit.
    Statistical analysis title
    Group A: 12-month GH Treatment, Group
    Statistical analysis description
    "D" represents a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.
    Comparison groups
    Group A: 12-month Growth Hormone Treatment v Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001 [2]
    Method
    ANOVA
    Parameter type
    Treatment-Contrast
    Point estimate
    5.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.09
         upper limit
    6.21
    Notes
    [2] - The Ht-V after 6 months of treatment was analysed using an analysis of variance (ANOVA) method with group and sex as fixed effects, and age as a covariate.

    Secondary: Change in Ht-SDS (Height Standard Deviation Score)

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    End point title
    Change in Ht-SDS (Height Standard Deviation Score)
    End point description
    HSDS were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from - 2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal. The analysis was performed on the FAS, which included all randomised subjects in Group A, who received at least one dose of the trial product and all randomised subjects in Group B.
    End point type
    Secondary
    End point timeframe
    From the baseline to 6-month of treatment.
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    32 [3]
    15
    Units: Standard Deviation Score (SDS)
        least squares mean (standard error)
    0.76 ± 0.04
    0.19 ± 0.06
    Notes
    [3] - Out of 36 exposed subjects, 4 subjects had missing values for height at baseline visit.
    No statistical analyses for this end point

    Secondary: Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)

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    End point title
    Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
    End point description
    IGF-I was measured at Visit 1 (screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6-month of treatment was calculated. The analysis was performed on the FAS, which included all randomised subjects in Group A, who received at least one dose of the trial product and all randomised subjects in Group B.
    End point type
    Secondary
    End point timeframe
    From the baseline to 6-month of treatment.
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    36
    15
    Units: ng/mL
        least squares mean (standard error)
    192.58 ± 14
    28.03 ± 21.81
    No statistical analyses for this end point

    Secondary: Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)

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    End point title
    Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
    End point description
    IGFBP-3 was measured at visit 1(screening), visit 3 (3 months ± 7 days ), visit 4 (6 months ± 7 days), visit 5 (9 months ± 7 days ) and visit 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6-month of treatment were calculated. The analysis was performed on the FAS, which included all randomised subjects in Group A, who received at least one dose of the trial product and all randomised subjects in Group B.
    End point type
    Secondary
    End point timeframe
    From the baseline to 6-month of treatment.
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    36
    15
    Units: μg/mL
        least squares mean (standard error)
    0.89 ± 0.19
    0.22 ± 0.3
    No statistical analyses for this end point

    Secondary: Ht-V (Height Velocity)

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    End point title
    Ht-V (Height Velocity) [4]
    End point description
    Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at visit 2 (day 0), visit 4 (6 months ± 7 days) and visit 6 (12 months ± 7 days), as follows: Between visits 2 and 4, between visits 4 and 6 and between visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment in group A. The analysis was performed on the FAS, which included all randomised subjects in Group A, who received at least one dose of the trial product and all randomised subjects in Group B.
    End point type
    Secondary
    End point timeframe
    At the first 6 months and the last 6 months in group A
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was evaluated only for the treatment arm, ‘Group A: 12-month Growth Hormone Treatment’ as per the trial protocol.
    End point values
    Group A: 12-month Growth Hormone Treatment
    Number of subjects analysed
    32 [5]
    Units: cm/year
        least squares mean (confidence interval 95%)
    2.8 (1.55 to 4.04)
    Notes
    [5] - Out of 36 exposed subjects, 4 subjects had missing values for height at baseline visit.
    No statistical analyses for this end point

    Secondary: Occurrence of Adverse Events (AEs)

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    End point title
    Occurrence of Adverse Events (AEs)
    End point description
    An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are treatment emergent. For Group A, a treatment emergent adverse event (TEAE) was defined as an event that has onset date on or after the first day of exposure to GH treatment (day 0) and no later than the last day of randomised treatment (month 12). For Group B, a TEAE was defined as an event that has onset date on or after Visit 2 (day 0) and no later than the last visit date (Visit 6 [month 12] for completers and withdrawal date for withdrawals). The analysis was performed on the safety analysis set (SAS), which included all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after visit 2 (day 0).
    End point type
    Secondary
    End point timeframe
    Throughout the trial (12 months).
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    36
    15
    Units: events
    70
    25
    No statistical analyses for this end point

    Secondary: Change in Bone Age

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    End point title
    Change in Bone Age
    End point description
    Plain X-rays of the left hand and wrist ex-posed for bone age appraisal were obtained at Visit 1 (screening), visit 4 (month 6) and 6 (month 12). For both group A and group B, change in bone age was evaluated from baseline to 6-month of treatment and from baseline to 12-month of treatment. The analysis was performed on the SAS, which included all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after visit 2 (day 0).
    End point type
    Secondary
    End point timeframe
    From baseline to 6-month of treatment and 12-month of treatment, respectively.
    End point values
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    36
    15
    Units: years
    arithmetic mean (standard deviation)
        Change from baseline to 6-month of treatment
    0.5 ± 0.2
    0.5 ± 0.2
        Change from baseline to 12-month of treatment
    1 ± 0.3
    1 ± 0.3
    No statistical analyses for this end point

    Secondary: Change in Bone Age; for Group B only

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    End point title
    Change in Bone Age; for Group B only [6]
    End point description
    Plain X-rays of the left hand and wrist ex-posed for bone age appraisal were obtained at Visit 1 (screening), visit 4 (month 6) and 6 (month 12). For group B, change in bone age was evaluated from 6 months to 12 months (i.e., last 6-month of treatment period). The analysis was performed on the SAS, which included all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after visit 2 (day 0).
    End point type
    Secondary
    End point timeframe
    For group B: From 6 months to 12 months.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was evaluated only for the treatment arm, ‘Group B: 6-month Untreated + 6-month Growth Hormone Treatment’ as per the trial protocol.
    End point values
    Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Number of subjects analysed
    15
    Units: Years
        arithmetic mean (standard deviation)
    0.5 ± 0.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the trial (12 months).
    Adverse event reporting additional description
    Safety analysis set included all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after visit 2 (day 0). All AEs mentioned here are treatment emergent, i.e., TEAEs.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Group A: 12-month Growth Hormone Treatment
    Reporting group description
    For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Reporting group title
    Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Reporting group description
    Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.

    Serious adverse events
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 36 (11.11%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group A: 12-month Growth Hormone Treatment Group B: 6-month Untreated + 6-month Growth Hormone Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 36 (55.56%)
    10 / 15 (66.67%)
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eye disorders
    Eye disorder
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    15 / 36 (41.67%)
    7 / 15 (46.67%)
         occurrences all number
    43
    14
    Rhinitis
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 36 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2012
    The change was the revision of height measurement method, statistical method (per protocol (PP) analysis to be conducted, 1st, 2nd exploratory purpose to be included in the secondary purpose.), In/Exclusion criteria (‘Bone age ≤ 12 years’ was added in the inclusion criteria and ‘Bone age is advanced over chronological age more than 3 years (inclusive)’ was added in the exclusion criteria).
    31 Oct 2012
    The change was the revision of IGF-I/ IGFBP-3, addition of withdrawal criterion, sample size adjustment, exclusion criteria, change of dose regimen, change of screening period, paper CRF, data management, central laboratory assessment, monitoring procedures and trial sites.

    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.
    None reported
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