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    Clinical Trial Results:
    An 8 day open-label, multiple-dose, multi-center study to evaluate the safety/tolerability and pharmacokinetics of aliskiren in hypertensive pediatric and adolescent patients 6 – 17 years of age.

    Summary
    EudraCT number
    		 2008-005802-37
    Trial protocol
    		 HU   BE   Outside EU/EEA  
    Global end of trial date
    08 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSPP100A2256
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,
    Scientific contact
    Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000362-PIP01-08
    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
    08 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the safety, tolerability, dose proportionality and age effect on pharmacokinetics of aliskiren minitablets administered in children (aged 6-17 years) suffering with hypertension after single and multiple doses.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all 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
    13 Apr 2009
    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
    Poland: 9
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    39
    EEA total number of subjects
    27
    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)
    20
    Adolescents (12-17 years)
    19
    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 study was conducted at 14 centres in 5 countries.

    Pre-assignment
    Screening details
    		 A total of 49 subjects were enrolled into the study of which, 39 subjects were randomized.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    As the study was an open label study, this section was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aliskiren 2 mg/kg
    Arm description
    		 Subjects received single dose of oral mini-tablets (3.125 milligram [mg]) of aliskiren at 2 milligram/kilogram (mg/kg) body weight daily for a total of 8 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aliskiren
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of oral mini-tablets (3.125 mg) of aliskiren at 2 mg/kg body weight daily for a total of 8 days.

    Arm title
    		 Aliskiren 6 mg/kg
    Arm description
    		 Subjects received single dose of oral mini-tablets (3.125 mg) of aliskiren at 6 mg/kg body weight daily for a total of 8 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aliskiren
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of oral mini-tablets (3.125 mg) of aliskiren at 6 mg/kg body weight daily for a total of 8 days.

    Number of subjects in period 1
    		Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Started
    19
    20
    Completed
    18
    19
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aliskiren 2 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 milligram [mg]) of aliskiren at 2 milligram/kilogram (mg/kg) body weight daily for a total of 8 days.

    Reporting group title
    Aliskiren 6 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 mg) of aliskiren at 6 mg/kg body weight daily for a total of 8 days.

    Reporting group values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg Total
    Number of subjects
    		 19 20 39
    Age categorical
    Units: Subjects
        6–11 years
    		 10 10 20
        12–17 years
    		 9 10 19
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.2 ( 3.12 ) 11.8 ( 3.78 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 8 18
        Male
    		 9 12 21

    End points

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    End points reporting groups
    Reporting group title
    Aliskiren 2 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 milligram [mg]) of aliskiren at 2 milligram/kilogram (mg/kg) body weight daily for a total of 8 days.

    Reporting group title
    Aliskiren 6 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 mg) of aliskiren at 6 mg/kg body weight daily for a total of 8 days.

    Primary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. The analysis was performed in safety population (SAF), defined as all the randomized subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 12
    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: Only descriptive summary statistics was planned for this primary outcome measure.
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: Number of subjects
        AEs
    10
    8
        SAEs
    0
    1
    No statistical analyses for this end point

    Primary: Maximum plasma concentration (Cmax) of aliskiren

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    End point title
    		 Maximum plasma concentration (Cmax) of aliskiren
    End point description
    Maximum observed plasma concentration following drug administration was determined from the raw plasma concentration-time data. The analysis was performed in pharmacokinetic (PK) population which included all subjects who had evaluable aliskiren concentration data with no protocol deviations that presumably affected PK results. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Primary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: nanograms/millilitres
    arithmetic mean (standard deviation)
        Day 1: 6-11 years old (n=10, 10)
    76.8 ( 78.21 )
    393.3 ( 377.37 )
        Day 8: 6-11 years old (n=9, 10)
    82.2 ( 97.85 )
    397.1 ( 187.06 )
        Day 1: 12-17 years old (n=9, 10)
    136.5 ( 132.57 )
    424.3 ( 188.79 )
        Day 8: 12-17 years old (n=9, 10)
    278.7 ( 357.54 )
    485.7 ( 300.58 )
    Statistical analysis title
    		 Cmax of aliskiren following single dose on Day 1
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the single dose Cmax of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.476
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.13
    Statistical analysis title
    		 Cmax of aliskiren at steady state on Day 8
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the steady state Cmax of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.534
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.13

    Primary: Area under the plasma concentration-time curve in one dosing interval (AUC0-24) of aliskiren

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    End point title
    		 Area under the plasma concentration-time curve in one dosing interval (AUC0-24) of aliskiren
    End point description
    Area under the plasma concentration-time curve in one dosing interval (24 h) was estimated from the raw plasma concentration time data. The analysis was performed in PK population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Primary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: hours*nanograms/millitres
    arithmetic mean (standard deviation)
        Day 1: 6-11 years old (n=10, 10)
    278.3 ( 237.29 )
    1231 ( 728.46 )
        Day 8: 6-11 years old (n=9, 10)
    403.6 ( 326.76 )
    1959.9 ( 821.43 )
        Day 1: 12-17 years old (n=9, 10)
    390.9 ( 264.5 )
    1808.7 ( 806.78 )
        Day 8: 12-17 years old (n=9, 10)
    847.2 ( 803.44 )
    2087 ( 999.1 )
    Statistical analysis title
    		 AUC0-24 of aliskiren following single dose on Day1
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the single dose AUC0-24 of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.233
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.11
    Statistical analysis title
    		 AUC0-24 of aliskiren at steady state on Day 8
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the steady state AUC0-24 of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.609
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    1.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.09

    Primary: Apparent plasma clearance (CL/F) of aliskiren

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    End point title
    		 Apparent plasma clearance (CL/F) of aliskiren
    End point description
    Apparent oral clearance of drug from the plasma (CL/F) was calculated as Dose/AUC0-∞, where CL was the clearance of the drug, F was the absolute oral bioavailability and AUC (0 - ∞) was area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). The analysis was performed in PK population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Primary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: millilitres/hours/kilograms
    arithmetic mean (standard deviation)
        6-11 years old (n=9, 10)
    9694 ( 8704.71 )
    3905.4 ( 2628.52 )
        12-17 years old (n=9, 10)
    5388.1 ( 5580.55 )
    3539 ( 1587.49 )
    Statistical analysis title
    		 CL/F of aliskiren following single dose on Day 1
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the single dose CL/F of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.233
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.02
    Statistical analysis title
    		 CL/F of aliskiren at steady state on Day 8
    Statistical analysis description
    Regression modelling was performed to evaluate the effect of age on the steady state CL/F of aliskiren.
    Comparison groups
    Aliskiren 2 mg/kg v Aliskiren 6 mg/kg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.609
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    0.98
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.05

    Primary: Time to maximum plasma concentration (Tmax) of aliskiren

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    End point title
    		 Time to maximum plasma concentration (Tmax) of aliskiren [2]
    End point description
    Tmax was defined as the time required to reach maximum observed plasma concentration following drug administration. Tmax was directly determined from the raw plasma concentration-time data. The analysis was performed in PK population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Primary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    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: Only descriptive summary statistics was planned for this primary outcome measure.
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: hours
    median (full range (min-max))
        Day 1: 6-11 years old (n=10, 10)
    1 (0.5 to 4.1)
    1.5 (0.5 to 4.1)
        Day 8: 6-11 years old (n=9, 10)
    1 (0.5 to 4)
    1.5 (0.5 to 6)
        Day 1: 12-17 years old (n=9, 10)
    1 (0.5 to 3)
    1.8 (0.5 to 4)
        Day 8: 12-17 years old (n=9, 10)
    1 (0.5 to 3)
    2 (0.5 to 3)
    No statistical analyses for this end point

    Primary: Terminal elimination half-life (t1/2) of aliskiren

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    End point title
    		 Terminal elimination half-life (t1/2) of aliskiren [3]
    End point description
    Terminal elimination half-life was estimated from the terminal slope of a semilogarithmic concentration-time curve. The analysis was performed in PK population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Primary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    Notes
    [3] - 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: Only descriptive summary statistics was planned for this primary outcome measure.
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20 [4]
    Units: hours
    arithmetic mean (standard deviation)
        6-11 years old (n=9, 10)
    38.8 ( 11.69 )
    45.1 ( 12.27 )
        12-17 years old (n=9, 10)
    39.2 ( 4.65 )
    42.9 ( 6.47 )
    Notes
    [4] - In 6–11 year old category(6 mg/kg), n =9 as one subject was excluded due to short sample collection.
    No statistical analyses for this end point

    Secondary: Accumulation index based on Cmax (AICmax) of aliskiren

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    End point title
    		 Accumulation index based on Cmax (AICmax) of aliskiren
    End point description
    Accumulation index based on Cmax was the ratio of Cmax values on Day 8 and Day 1. The analysis was performed in PK population.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: ratio
    arithmetic mean (standard deviation)
        6-11 years old (n=9, 10)
    1.5 ( 1.32 )
    3.3 ( 6.22 )
        12-17 years old (n=9, 10)
    2.9 ( 3.4 )
    1.2 ( 0.68 )
    No statistical analyses for this end point

    Secondary: Accumulation index based on AUC (AIAUC) of aliskiren

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    End point title
    		 Accumulation index based on AUC (AIAUC) of aliskiren
    End point description
    Accumulation index based on AUC was the ratio of AUC values on Day 8 and Day 1. The analysis was performed in PK population.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose on Day 1 and at 48, 72 and 96 hours post dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: ratio
    arithmetic mean (standard deviation)
        6-11 years old (n=9, 10)
    1.9 ( 1.01 )
    2.2 ( 1.93 )
        12-17 years old (n=9, 10)
    2.1 ( 1.29 )
    1.3 ( 0.64 )
    No statistical analyses for this end point

    Secondary: Change from baseline in plasma renin activity (PRA) at Days 1, 8 and 9

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    End point title
    		 Change from baseline in plasma renin activity (PRA) at Days 1, 8 and 9
    End point description
    Pharmacodynamics (PD) of aliskiren was assessed based on the changes in plasma renin activity (PRA) using a high sensitivity PRA assay. Negative change from baseline in PRA indicated improvement. The analysis was performed in Full analysis set (FAS) population, which included all randomized subjects. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: nanograms/millilitres/hours
    arithmetic mean (standard deviation)
        Day 1: 2 hour post-dose (n=15, 15)
    -1.8 ( 1.62 )
    -4 ( 6.68 )
        Day 1: 10 hour post-dose ( n=14, 13)
    -1.8 ( 1.73 )
    -3.8 ( 6.79 )
        Day 8: pre-dose (n=14, 15)
    -1.3 ( 1.77 )
    -3.5 ( 5.91 )
        Day 8: 2 hour post-dose (n=11, 14)
    -1.4 ( 1.6 )
    -3.6 ( 6.79 )
        Day 8: 10 hour post dose (n=13, 15)
    -1.7 ( 1.81 )
    -3.8 ( 6.41 )
        Day 8: 24 hour post dose ( n=13, 15)
    -1.5 ( 1.82 )
    -3.6 ( 6.46 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) at Day 9

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    End point title
    		 Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) at Day 9
    End point description
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2-3 minute intervals and the average of three sitting systolic or diastolic blood pressure measurements were used as the initial mean sitting systolic office blood pressure (MsSBP) or mean sitting diastolic office blood pressure (MsDBP) for that visit. Change from baseline in MsSBP and MsDBP was evaluated. Negative change from baseline in msSBP and msDBP indicated improvement i.e reduction in BP. The analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 9
    End point values
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Number of subjects analysed
    19
    20
    Units: millimeters of mercury
    arithmetic mean (standard deviation)
        msSBP: 6-11 years old (n=10, 10)
    -4.5 ( 14.63 )
    -7.7 ( 11.76 )
        msSBP: 12-17 years old (n=9, 10)
    -7.6 ( 9.07 )
    -7.7 ( 9.38 )
        msDBP: 6-11 years old ( n=10, 10)
    -1.7 ( 4.69 )
    0 ( 8.87 )
        msDBP: 12-17 years old ( n=9, 10)
    -5.3 ( 8.78 )
    -5.8 ( 8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs are monitored from date of First Subject First Visit (FSFV) until 30 days after Last Subject Last Visit (LSLV) or last treatment. All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Aliskiren 2 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 mg) of aliskiren at 2 mg/kg body weight daily for a total of 8 days.

    Reporting group title
    Aliskiren 6 mg/kg
    Reporting group description
    		 Subjects received single dose of oral mini-tablets (3.125 mg) of aliskiren at 6 mg/kg body weight daily for a total of 8 days.

    Serious adverse events
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Swine influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         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
    		 Aliskiren 2 mg/kg Aliskiren 6 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 19 (52.63%)
    7 / 20 (35.00%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 20 (10.00%)
         occurrences all number
    5
    2
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Feb 2009
    1. Clarified the exclusion criteria of HIV, hepatitis B, and hepatitis tests 2. Modified the blood volume required for PD evaluation 3. Clarified the addition and optional use of heparin to flush the intravenous (i.v.) lock used for PK and PD blood draws.

    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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