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    Clinical Trial Results:
    A 6 week, randomized, multicenter, double-blind, double dummy study to evaluate the dose response of valsartan on blood pressure reduction in children 1-5 years old with hypertension, with or without chronic kidney disease, followed by a 20 week open-label titration phase

    Summary
    EudraCT number
    		 2011-005991-40
    Trial protocol
    		 BE   HU   DE   IT   PL   FR   ES   LT  
    Global end of trial date
    24 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2017
    First version publication date
    09 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVAL489K2306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01617681
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000005-PIP01-07
    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
    24 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if a dose dependent reduction in mean systolic blood pressure (MSBP) exists when comparing two doses of valsartan solution (0.25 mg/kg/day and 4 mg/kg/day) over a 6 week period in children 1-5 years old with hypertension (MSBP ≥95th percentile for age, gender and height), with or without chronic kidney disease (CKD).
    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
    07 Nov 2012
    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
    Belgium: 7
    Country: Number of subjects enrolled
    Brazil: 36
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Guatemala: 20
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Lithuania: 6
    Country: Number of subjects enrolled
    Poland: 37
    Worldwide total number of subjects
    127
    EEA total number of subjects
    71
    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)
    31
    Children (2-11 years)
    96
    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
    		 -

    Pre-assignment
    Screening details
    		 Overall, 156 patients were screened, of which 127 patients were enrolled in the double blind period 1 of the study. A total of 120 patients (94.5%) completed Period 1 and entered Open Label Period 2. Parallel= Period 1 (Double Blind phase) Single= Period 2 (Open Label phase)

    Period 1
    Period 1 title
    Period 1 Double Blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CKD patients Valsartan 0.25 mg/kg
    Arm description
    		 CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valsartan 0.25 mg/kg/day oral solution for 6 weeks

    Arm title
    		 CKD patients Valsartan 4 mg/kg
    Arm description
    		 CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valsartan 4 mg/kg/day oral solution for 6 weeks

    Arm title
    		 Non-CKD patients Valsartan 0.25 mg/kg
    Arm description
    		 Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valsartan 0.25 mg/kg/day oral solution for 6 weeks

    Arm title
    		 Non-CKD patients Valsartan 4 mg/kg
    Arm description
    		 Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valsartan 4 mg/kg/day oral solution for 6 weeks

    Number of subjects in period 1
    		CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg Non-CKD patients Valsartan 0.25 mg/kg Non-CKD patients Valsartan 4 mg/kg
    Started
    32
    31
    33
    31
    Full Analysis Set (FAS)
    31
    31
    33
    31
    Completed
    29
    30
    32
    29
    Not completed
    3
    1
    1
    2
         Consent withdrawn by subject
    1
    1
    1
    -
         Adverse event, non-fatal
    2
    -
    -
    2
    Period 2
    Period 2 title
    Period 2 Open Label
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Valsartan 1 mg/kg (Period 2)
    Arm description
    		 Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valsartan 1 mg/kg/day oral solution for 20 weeks

    Number of subjects in period 2
    		Valsartan 1 mg/kg (Period 2)
    Started
    120
    Completed
    114
    Not completed
    6
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CKD patients Valsartan 0.25 mg/kg
    Reporting group description
    		 CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    CKD patients Valsartan 4 mg/kg
    Reporting group description
    		 CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    Non-CKD patients Valsartan 0.25 mg/kg
    Reporting group description
    		 Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    Non-CKD patients Valsartan 4 mg/kg
    Reporting group description
    		 Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)

    Reporting group values
    		 CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg Non-CKD patients Valsartan 0.25 mg/kg Non-CKD patients Valsartan 4 mg/kg Total
    Number of subjects
    		 32 31 33 31 127
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 10 12 5 4 31
        Children (2-11 years)
    		 22 19 28 27 96
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.99 ( 1.47 ) 2.72 ( 1.33 ) 3.7 ( 1.51 ) 3.62 ( 1.36 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 12 8 14 13 47
        Male
    		 20 23 19 18 80

    End points

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    End points reporting groups
    Reporting group title
    CKD patients Valsartan 0.25 mg/kg
    Reporting group description
    		 CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    CKD patients Valsartan 4 mg/kg
    Reporting group description
    		 CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    Non-CKD patients Valsartan 0.25 mg/kg
    Reporting group description
    		 Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)

    Reporting group title
    Non-CKD patients Valsartan 4 mg/kg
    Reporting group description
    		 Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
    Reporting group title
    Valsartan 1 mg/kg (Period 2)
    Reporting group description
    		 Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.

    Primary: Change from baseline in mean systolic blood pressure (MSBP) at Week 6 endpoint

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    End point title
    		 Change from baseline in mean systolic blood pressure (MSBP) at Week 6 endpoint
    End point description
    Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase
    End point type
    Primary
    End point timeframe
    Baseline, week 6
    End point values
    		 CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg Non-CKD patients Valsartan 0.25 mg/kg Non-CKD patients Valsartan 4 mg/kg
    Number of subjects analysed
    31
    31
    33
    31
    Units: mmHg
        least squares mean (standard error)
    -1.2 ( 2.05 )
    -9.2 ( 2.05 )
    -6.9 ( 1.44 )
    -7.8 ( 1.48 )
    Statistical analysis title
    		 Change from baseline in MSBP at Week 6
    Comparison groups
    CKD patients Valsartan 0.25 mg/kg v CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0096
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.86
         upper limit
    		 -2.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.96
    Statistical analysis title
    		 Change from baseline in MSBP at Week 6
    Comparison groups
    Non-CKD patients Valsartan 0.25 mg/kg v Non-CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6531
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.07

    Secondary: Change from baseline in mean diastolic blood pressure (MDBP) at Week 6

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    End point title
    		 Change from baseline in mean diastolic blood pressure (MDBP) at Week 6
    End point description
    Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg Non-CKD patients Valsartan 0.25 mg/kg Non-CKD patients Valsartan 4 mg/kg
    Number of subjects analysed
    31
    31
    33
    31
    Units: mmHg
        least squares mean (standard error)
    1.3 ( 1.79 )
    -6.5 ( 1.79 )
    -1.9 ( 1.26 )
    -7.2 ( 1.3 )
    Statistical analysis title
    		 Change from baseline in MDBP at Week 6
    Comparison groups
    CKD patients Valsartan 0.25 mg/kg v CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.94
         upper limit
    		 -2.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.54
    Statistical analysis title
    		 Change from baseline in MDBP at Week 6
    Comparison groups
    Non-CKD patients Valsartan 0.25 mg/kg v Non-CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0042
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.98
         upper limit
    		 -1.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8

    Secondary: Patients achieving <90th percentile for age, gender and height at Week 6 endpoint in both MSBP and MDBP

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    End point title
    		 Patients achieving <90th percentile for age, gender and height at Week 6 endpoint in both MSBP and MDBP
    End point description
    Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg Non-CKD patients Valsartan 0.25 mg/kg Non-CKD patients Valsartan 4 mg/kg
    Number of subjects analysed
    31
    31
    33
    31
    Units: participants
    6
    9
    7
    8
    Statistical analysis title
    		 Achieving<90th% for age,gender&height in MSBP&MDBP
    Comparison groups
    CKD patients Valsartan 0.25 mg/kg v CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.411
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 5.8
    Statistical analysis title
    		 Achieving<90th% for age,gender&height in MSBP&MDBP
    Comparison groups
    Non-CKD patients Valsartan 0.25 mg/kg v Non-CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5443
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 4.79

    Secondary: CKD patients achieving urine albumin creatinine ratio percentage reduction (UACR) >=25% at Week 6

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    End point title
    		 CKD patients achieving urine albumin creatinine ratio percentage reduction (UACR) >=25% at Week 6 [1]
    End point description
    UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.
    End point type
    Secondary
    End point timeframe
    Week 6 weeks
    Notes
    [1] - 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 only looked at CKD patients
    End point values
    		 CKD patients Valsartan 0.25 mg/kg CKD patients Valsartan 4 mg/kg
    Number of subjects analysed
    27
    27
    Units: participants
    12
    9
    Statistical analysis title
    		 CKD patients achieving UACR >=25% at Week 6
    Comparison groups
    CKD patients Valsartan 0.25 mg/kg v CKD patients Valsartan 4 mg/kg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2624
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.517
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.64

    Adverse events

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    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Valsartan 0.25 mg/kg
    Reporting group description
    		 Valsartan 0.25 mg/kg

    Reporting group title
    All open label Patients
    Reporting group description
    		 All open label Patients

    Reporting group title
    Valsartan 4.0 mg/kg
    Reporting group description
    		 Valsartan 4.0 mg/kg

    Serious adverse events
    		 Valsartan 0.25 mg/kg All open label Patients Valsartan 4.0 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 64 (3.13%)
    6 / 120 (5.00%)
    2 / 62 (3.23%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Toxicity to various agents
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 120 (0.83%)
    0 / 62 (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
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 120 (0.83%)
    0 / 62 (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
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 120 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 120 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 120 (0.83%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 120 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 120 (1.67%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 120 (0.83%)
    0 / 62 (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
    Pharyngitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 120 (0.83%)
    0 / 62 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Valsartan 0.25 mg/kg All open label Patients Valsartan 4.0 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 64 (29.69%)
    62 / 120 (51.67%)
    13 / 62 (20.97%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 64 (3.13%)
    20 / 120 (16.67%)
    3 / 62 (4.84%)
         occurrences all number
    3
    27
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 64 (6.25%)
    10 / 120 (8.33%)
    2 / 62 (3.23%)
         occurrences all number
    4
    13
    2
    Vomiting
         subjects affected / exposed
    3 / 64 (4.69%)
    9 / 120 (7.50%)
    1 / 62 (1.61%)
         occurrences all number
    3
    9
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 64 (7.81%)
    11 / 120 (9.17%)
    1 / 62 (1.61%)
         occurrences all number
    5
    13
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 64 (4.69%)
    7 / 120 (5.83%)
    0 / 62 (0.00%)
         occurrences all number
    3
    9
    0
    Ear infection
         subjects affected / exposed
    0 / 64 (0.00%)
    7 / 120 (5.83%)
    0 / 62 (0.00%)
         occurrences all number
    0
    8
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 64 (4.69%)
    9 / 120 (7.50%)
    2 / 62 (3.23%)
         occurrences all number
    5
    11
    2
    Respiratory tract infection
         subjects affected / exposed
    4 / 64 (6.25%)
    6 / 120 (5.00%)
    3 / 62 (4.84%)
         occurrences all number
    6
    10
    3
    Tonsillitis
         subjects affected / exposed
    0 / 64 (0.00%)
    8 / 120 (6.67%)
    2 / 62 (3.23%)
         occurrences all number
    0
    8
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    10 / 120 (8.33%)
    0 / 62 (0.00%)
         occurrences all number
    1
    12
    0

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    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.
    None reported
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    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.

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