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    Clinical Trial Results:
    A multicenter, open-label, 18 month study to evaluate the long-term safety and tolerability of valsartan in children 6 to 17 years of age with hypertension and with or without chronic kidney disease

    Summary
    EudraCT number
    		 2009-017594-37
    Trial protocol
    		 DE   FI   PL  
    Global end of trial date
    11 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2016
    First version publication date
    14 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVAL489K2305
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01365481
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, 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
    04 Aug 2011
    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
    Colombia: 7
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Guatemala: 27
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Philippines: 34
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Romania: 16
    Country: Number of subjects enrolled
    Russian Federation: 23
    Country: Number of subjects enrolled
    Singapore: 7
    Worldwide total number of subjects
    150
    EEA total number of subjects
    45
    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)
    45
    Adolescents (12-17 years)
    105
    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
    		 A 1 arm study of valsartan but with 2 groups for analyses. These 2 groups were not randomized and considered to be 2 different populations since the patients in the valsartan+antihypertensive group had concomitant antihypertensive usage per individual patient's conditions at any time during treatment period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CKD Patients: valsartan + antihypertensive group
    Arm description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    valsartan
    Investigational medicinal product code
    val489
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    valsartan 80mg/160mg/320mg/day oral tablet for 78 weeks

    Arm title
    		 CKD Patients: valsartan alone
    Arm description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    valsartan
    Investigational medicinal product code
    val489
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    valsartan 80mg/160mg/320mg/day oral tablet for 78 weeks

    Arm title
    		 Non-CKD Patients: valsartan + antihypertensive group
    Arm description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    valsartan
    Investigational medicinal product code
    val489
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    valsartan 80mg/160mg/320mg/day oral tablet for 78 weeks

    Arm title
    		 Non-CKD Patients: valsartan alone
    Arm description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    valsartan
    Investigational medicinal product code
    val489
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    valsartan 80mg/160mg/320mg/day oral tablet for 78 weeks

    Number of subjects in period 1
    		CKD Patients: valsartan + antihypertensive group CKD Patients: valsartan alone Non-CKD Patients: valsartan + antihypertensive group Non-CKD Patients: valsartan alone
    Started
    23
    52
    18
    57
    Completed
    16
    37
    14
    50
    Not completed
    7
    15
    4
    7
         Abnormal laboratory value(s)
    -
    1
    -
    -
         Consent withdrawn by subject
    -
    2
    1
    1
         Adverse event, non-fatal
    6
    9
    -
    2
         Protocol deviation
    -
    1
    -
    1
         Unsatisfactory therapeutic effect
    -
    -
    1
    -
         Administrative problems
    -
    1
    -
    -
         Lost to follow-up
    1
    1
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CKD Patients: valsartan + antihypertensive group
    Reporting group description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Reporting group title
    CKD Patients: valsartan alone
    Reporting group description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Reporting group title
    Non-CKD Patients: valsartan + antihypertensive group
    Reporting group description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Reporting group title
    Non-CKD Patients: valsartan alone
    Reporting group description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Reporting group values
    		 CKD Patients: valsartan + antihypertensive group CKD Patients: valsartan alone Non-CKD Patients: valsartan + antihypertensive group Non-CKD Patients: valsartan alone Total
    Number of subjects
    		 23 52 18 57 150
    Age, Customized
    Units: participants
        6 – 11 years
    		 10 22 3 10 45
        12 – 17 years
    		 13 30 15 47 105
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.9 ± 3.35 12.3 ± 3.2 13.79 ± 2.64 14.37 ± 2.83 -
    Gender, Male/Female
    Units: participants
        Male
    		 11 36 15 37 99
        Female
    		 12 16 3 20 51

    End points

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    End points reporting groups
    Reporting group title
    CKD Patients: valsartan + antihypertensive group
    Reporting group description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Reporting group title
    CKD Patients: valsartan alone
    Reporting group description
    		 CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Reporting group title
    Non-CKD Patients: valsartan + antihypertensive group
    Reporting group description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Reporting group title
    Non-CKD Patients: valsartan alone
    Reporting group description
    		 Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Subject analysis set title
    valsartan + antihypertensive group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Subject analysis set title
    valsartan alone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Subject analysis set title
    valsartan + antihypertensive group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

    Subject analysis set title
    valsartan alone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.

    Primary: Change from baseline in mean sitting systolic blood pressure (msSBP) at End Point (Week 78 or Last observation carried forward (LOCF)

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    End point title
    		 Change from baseline in mean sitting systolic blood pressure (msSBP) at End Point (Week 78 or Last observation carried forward (LOCF) [1]
    End point description
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit. No statistical analysis was planned for this primary outcome
    End point type
    Primary
    End point timeframe
    Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
    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 planned for this primary outcome.
    End point values
    		 valsartan + antihypertensive group valsartan alone
    Number of subjects analysed
    41
    109
    Units: millimeter(s) of mercury (mmHg)
        arithmetic mean (standard deviation)
    -13.3 ± 13.69
    -15.5 ± 13.35
    No statistical analyses for this end point

    Primary: Change from baseline in mean sitting diastolic blood pressure (MsDBP) at End Point (Week 78 or Last observation carried forward (LOCF)

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    End point title
    		 Change from baseline in mean sitting diastolic blood pressure (MsDBP) at End Point (Week 78 or Last observation carried forward (LOCF) [2]
    End point description
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
    Notes
    [2] - 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 planned for this primary outcome.
    End point values
    		 valsartan + antihypertensive group valsartan alone
    Number of subjects analysed
    41
    109
    Units: millimeter(s) of mercury (mmHg)
        arithmetic mean (standard deviation)
    -10.3 ± 11.94
    -10.8 ± 11.45
    No statistical analyses for this end point

    Secondary: Number of participants with MSSBP, MSDBP and (MSSBP and MSDBP combined) < 95th percentile for gender, age, and height

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    End point title
    		 Number of participants with MSSBP, MSDBP and (MSSBP and MSDBP combined) < 95th percentile for gender, age, and height
    End point description
    Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height
    End point type
    Secondary
    End point timeframe
    End Point (Week 78 or Last observation carried forward (LOCF)
    End point values
    		 valsartan + antihypertensive group valsartan alone
    Number of subjects analysed
    41
    109
    Units: Number of Participants
        MSSBP (n=39, 105)
    23
    90
        MSDBP (n=28, 51)
    20
    47
        MSSBP and MSDBP combined (n=40, 105)
    22
    88
    No statistical analyses for this end point

    Secondary: Percentage of Chronic Kidney Disease (CKD) patients who had >=50% reduction in urine albumin/creatinine ratio (UACR) from Baseline to end point

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    End point title
    		 Percentage of Chronic Kidney Disease (CKD) patients who had >=50% reduction in urine albumin/creatinine ratio (UACR) from Baseline to end point
    End point description
    Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline
    End point type
    Secondary
    End point timeframe
    Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
    End point values
    		 valsartan + antihypertensive group valsartan alone
    Number of subjects analysed
    23
    52
    Units: Percentage of patients
        number (not applicable)
    50
    41.9
    No statistical analyses for this end point

    Secondary: Percentage of Chronic Kidney Disease (CKD) patients who had estimated Glomerular Filtration Rate (eGFR) decrease > 25 % from Baselinefrom Baseline to end point

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    End point title
    		 Percentage of Chronic Kidney Disease (CKD) patients who had estimated Glomerular Filtration Rate (eGFR) decrease > 25 % from Baselinefrom Baseline to end point
    End point description
    Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline
    End point type
    Secondary
    End point timeframe
    Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
    End point values
    		 valsartan + antihypertensive group valsartan alone
    Number of subjects analysed
    23
    52
    Units: Percentage of patients
        number (not applicable)
    30.4
    27.5
    No statistical analyses for this end point

    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
    18.1
    Reporting groups
    Reporting group title
    Valsartan + antihyp.
    Reporting group description
    		 Valsartan + antihyp.

    Reporting group title
    Valsartan
    Reporting group description
    		 Valsartan

    Reporting group title
    CKD: Valsartan + antihyp
    Reporting group description
    		 CKD: Valsartan + antihyp

    Reporting group title
    CKD: Valsartan
    Reporting group description
    		 CKD: Valsartan

    Reporting group title
    Non-CKD: Valsartan + antihyp
    Reporting group description
    		 Non-CKD: Valsartan + antihyp

    Reporting group title
    Non-CKD:Valsartan
    Reporting group description
    		 Non-CKD:Valsartan

    Serious adverse events
    		 Valsartan + antihyp. Valsartan CKD: Valsartan + antihyp CKD: Valsartan Non-CKD: Valsartan + antihyp Non-CKD:Valsartan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 41 (19.51%)
    7 / 109 (6.42%)
    7 / 23 (30.43%)
    4 / 52 (7.69%)
    1 / 18 (5.56%)
    3 / 57 (5.26%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal polyp
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Drug abuse
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IgA nephropathy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 109 (0.92%)
    3 / 23 (13.04%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    1 / 23 (4.35%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Valsartan + antihyp. Valsartan CKD: Valsartan + antihyp CKD: Valsartan Non-CKD: Valsartan + antihyp Non-CKD:Valsartan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 41 (82.93%)
    68 / 109 (62.39%)
    18 / 23 (78.26%)
    36 / 52 (69.23%)
    16 / 18 (88.89%)
    32 / 57 (56.14%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 109 (1.83%)
    2 / 23 (8.70%)
    2 / 52 (3.85%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    4
    2
    4
    2
    0
    0
    Pallor
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 41 (19.51%)
    17 / 109 (15.60%)
    4 / 23 (17.39%)
    6 / 52 (11.54%)
    4 / 18 (22.22%)
    11 / 57 (19.30%)
         occurrences all number
    17
    46
    11
    12
    6
    34
    Headache
         subjects affected / exposed
    14 / 41 (34.15%)
    23 / 109 (21.10%)
    8 / 23 (34.78%)
    11 / 52 (21.15%)
    6 / 18 (33.33%)
    12 / 57 (21.05%)
         occurrences all number
    27
    70
    21
    19
    6
    51
    Hypoaesthesia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 109 (0.92%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    2
    2
    1
    0
    1
    2
    Chest pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    12 / 41 (29.27%)
    18 / 109 (16.51%)
    8 / 23 (34.78%)
    12 / 52 (23.08%)
    4 / 18 (22.22%)
    6 / 57 (10.53%)
         occurrences all number
    17
    29
    12
    19
    5
    10
    Eye disorders
    Myopia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    Retinal vascular disorder
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 41 (9.76%)
    7 / 109 (6.42%)
    2 / 23 (8.70%)
    4 / 52 (7.69%)
    2 / 18 (11.11%)
    3 / 57 (5.26%)
         occurrences all number
    9
    11
    6
    4
    3
    7
    Abdominal pain upper
         subjects affected / exposed
    2 / 41 (4.88%)
    5 / 109 (4.59%)
    2 / 23 (8.70%)
    2 / 52 (3.85%)
    0 / 18 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    4
    8
    4
    3
    0
    5
    Constipation
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 41 (4.88%)
    8 / 109 (7.34%)
    1 / 23 (4.35%)
    5 / 52 (9.62%)
    1 / 18 (5.56%)
    3 / 57 (5.26%)
         occurrences all number
    2
    8
    1
    5
    1
    3
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 109 (2.75%)
    2 / 23 (8.70%)
    2 / 52 (3.85%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    2
    3
    2
    2
    0
    1
    Toothache
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 109 (0.92%)
    2 / 23 (8.70%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    4
    1
    2
    0
    2
    1
    Vomiting
         subjects affected / exposed
    5 / 41 (12.20%)
    4 / 109 (3.67%)
    4 / 23 (17.39%)
    3 / 52 (5.77%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    8
    7
    7
    6
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 41 (43.90%)
    18 / 109 (16.51%)
    12 / 23 (52.17%)
    12 / 52 (23.08%)
    6 / 18 (33.33%)
    6 / 57 (10.53%)
         occurrences all number
    35
    52
    23
    32
    12
    20
    Dyspnoea
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 109 (1.83%)
    0 / 23 (0.00%)
    2 / 52 (3.85%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    2
    0
    2
    1
    0
    Epistaxis
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 109 (0.92%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    4
    2
    1
    0
    3
    2
    Nasal congestion
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 109 (0.92%)
    1 / 23 (4.35%)
    1 / 52 (1.92%)
    2 / 18 (11.11%)
    0 / 57 (0.00%)
         occurrences all number
    3
    1
    1
    1
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 109 (1.83%)
    1 / 23 (4.35%)
    1 / 52 (1.92%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    3
    4
    1
    2
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 109 (0.00%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 109 (2.75%)
    3 / 23 (13.04%)
    2 / 52 (3.85%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    4
    3
    3
    2
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 109 (1.83%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    1
    2
    0
    1
    1
    1
    Papule
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 109 (2.75%)
    0 / 23 (0.00%)
    3 / 52 (5.77%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    5
    0
    5
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 41 (2.44%)
    4 / 109 (3.67%)
    1 / 23 (4.35%)
    3 / 52 (5.77%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    2
    4
    2
    3
    0
    1
    Neck pain
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    2 / 18 (11.11%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 109 (0.00%)
    2 / 23 (8.70%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    2
    0
    1
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    1 / 52 (1.92%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    Enterobiasis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 109 (0.92%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    Influenza
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 109 (0.92%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    2 / 18 (11.11%)
    1 / 57 (1.75%)
         occurrences all number
    4
    1
    2
    0
    2
    1
    Mycoplasma infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 41 (26.83%)
    22 / 109 (20.18%)
    7 / 23 (30.43%)
    14 / 52 (26.92%)
    4 / 18 (22.22%)
    8 / 57 (14.04%)
         occurrences all number
    27
    76
    18
    46
    9
    30
    Pharyngitis
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 109 (0.00%)
    2 / 23 (8.70%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 109 (3.67%)
    1 / 23 (4.35%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    4 / 57 (7.02%)
         occurrences all number
    6
    5
    4
    0
    2
    5
    Rhinitis
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 109 (2.75%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    0 / 18 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    17 / 109 (15.60%)
    1 / 23 (4.35%)
    12 / 52 (23.08%)
    1 / 18 (5.56%)
    5 / 57 (8.77%)
         occurrences all number
    3
    36
    1
    28
    2
    8
    Urinary tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 109 (2.75%)
    2 / 23 (8.70%)
    2 / 52 (3.85%)
    0 / 18 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    2
    3
    2
    2
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    4 / 109 (3.67%)
    1 / 23 (4.35%)
    4 / 52 (7.69%)
    0 / 18 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    1
    7
    1
    7
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 109 (0.00%)
    0 / 23 (0.00%)
    0 / 52 (0.00%)
    1 / 18 (5.56%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2011
    Amendment 1: Estimated GFR <30 mL/min/1.73m2 was added as a reason for study discontinuation;complied with the current valsartan core data sheet, which does not recommend valsartan to be used in severely renal impaired pediatric patients (i.e. GFR <30 mL/min/1.73m2).Hemoglobin <8 g/dL was added as additional exclusion criteria.Text regarding immunosuppressive and steroid therapy was added to the prohibited treatment list to provide guidance to the study investigators. A statement regarding immunosuppressive therapy was also removed from the exclusion criteria.Bicarbonate (total CO2) was added as an additional lab parameter. At least 40% of patients enrolled were to have CKD.Revisions to visit and dosing times were added, in order to allow for morning or afternoon study visits. This added additional flexibility to the timing of study visits.
    14 May 2014
    Amendment 2: Enrollment was complete with 150 patients. Enrolled patients meeting the revised CKD definition that included Stage 1 CKD (eGFR ≥ 90mL/min/1.73m2)were classified as such. This revised definition of CKD is consistent with the CKD definition from the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI).This revision removed the requirement that CKD patients need an eGFR < 90 mL/min/1.73m2 for ≥ 3 months to be considered CKD patients. There was no impact on study procedures or patient safety. This protocol amendment allowed:Non-CKD patients to be potentially re-classified following adjudication as having Stage 1 CKD, should they meet Stage 1 CKD criteria.Non-CKD patients who were misclassified by the investigator as having CKD using the original protocol definition were to be potentially classified as Stage 1 CKD following adjudication.Patients continued following the same study assessments they had been following since initial treatment assignment. For example, patients who had morning urine collections done for UACR continued to have urine collections for UACR. Patients who never had morning collections for UACR were not required to begin morning UACR collections because a baseline sample had not been collected.

    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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