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    Clinical Trial Results:
    Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)

    Summary
    EudraCT number
    		 2012-000250-55
    Trial protocol
    		 AT  
    Global end of trial date
    25 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RASQAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01827202
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    Study investigator, Medical University of Vienna, marlies.antlanger@kepleruniklinikum.at
    Scientific contact
    Study investigator, Medical University of Vienna, marlies.antlanger@kepleruniklinikum.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.
    Protection of trial subjects
    Clinical and laboratory control one week after initiation of study medication. Biweekly clinical and laboratory controls thereafter. Patients were given the opportunity to contact study staff at all times by phone.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited from the outpatient Nephrology clinic of the Medical University of Vienna. Patients were recruited from December 13th, 2012 to November 12th, 2015.

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Chronic kidney disease stages III-IV (defined by MDRD formula) - Urinary albumin to creatinine ratio (UACR) >300mg/g, UACR >200mg/g if already receiving RAS blockade - Hypertension --> 2-week run-in phase after inclusion: standardization of blood pressure medication, no RAS-blocking agent

    Period 1
    Period 1 title
    Baseline visit
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Candesartan
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atacand
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg once daily for 4 weeks, thereafter 16 mg once daily for 4 weeks

    Arm title
    		 Aliskiren
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rasilez
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg once daily for 4 weeks, thereafter 300 mg once daily for 4 weeks.

    Number of subjects in period 1
    		Candesartan Aliskiren
    Started
    12
    12
    Baseline visit
    12
    12
    Completed
    12
    12
    Period 2
    Period 2 title
    Study end visit
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Candesartan
    Arm description
    		 -
    Arm type
    		 Comparator

    Investigational medicinal product name
    Atacand
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg once daily for 4 weeks, thereafter 16 mg once daily for 4 weeks

    Arm title
    		 Aliskiren
    Arm description
    		 -
    Arm type
    		 Intervention

    Investigational medicinal product name
    Rasilez
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg once daily for 4 weeks, thereafter 300 mg once daily for 4 weeks.

    Number of subjects in period 2
    		Candesartan Aliskiren
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Aliskiren
    Reporting group description
    		 -

    Reporting group values
    		 Candesartan Aliskiren Total
    Number of subjects
    		 12 12 24
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 15 ) 51 ( 14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 4 6
        Male
    		 10 8 18
    Angiotensin I
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    		 75.8 (45.5 to 130.4) 68.8 (19.6 to 136.4) -
    Angiotensin II
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    		 109.6 (32.4 to 164.6) 65 (34.4 to 132) -
    Angiotensin 1-7
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    		 1.2 (1.1 to 1.6) 1.2 (1.1 to 1.3) -

    End points

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    End points reporting groups
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Aliskiren
    Reporting group description
    		 -
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Aliskiren
    Reporting group description
    		 -

    Primary: Angiotensin I

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    End point title
    		 Angiotensin I
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Candesartan Aliskiren Candesartan Aliskiren
    Number of subjects analysed
    12 [1]
    12 [2]
    12 [3]
    12 [4]
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    332.8 (187.3 to 563)
    6.8 (2.1 to 13.3)
    75.8 (45.5 to 130.4)
    68.8 (19.6 to 136.4)
    Notes
    [1] - End of study
    [2] - End of study
    [3] - Baseline
    [4] - Baseline
    Statistical analysis title
    		 Angiotensin I pre/post
    Statistical analysis description
    Comparison of Angiotensin I change with Candesartan versus Aliskiren treatment
    Comparison groups
    Candesartan v Aliskiren v Candesartan v Aliskiren
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - Wilcoxon signed-rank test was applied to compare Angiotensin change within the Candesartan and within the Aliskiren group.

    Primary: Angiotensin II

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    End point title
    		 Angiotensin II
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Candesartan Aliskiren Candesartan Aliskiren
    Number of subjects analysed
    12
    12
    12 [6]
    12 [7]
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    442.9 (292.2 to 635)
    14.4 (1.7 to 28.2)
    109.6 (32.4 to 164.6)
    65 (34.4 to 132)
    Notes
    [6] - Baseline
    [7] - Baseline
    Statistical analysis title
    		 Angiotensin II pre/post
    Statistical analysis description
    Comparison of Angiotensin II levels before and after treatment with Candesartan or Aliskiren
    Comparison groups
    Candesartan v Aliskiren v Candesartan v Aliskiren
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - Wilcoxon signed-rank test was applied to compare Angiotensin II levels before and after Candesartan or Aliskiren treatment.

    Primary: Angiotensin 1-7

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    End point title
    		 Angiotensin 1-7
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Candesartan Aliskiren Candesartan Aliskiren
    Number of subjects analysed
    12
    12
    12 [9]
    12 [10]
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    1.3 (1.3 to 10.1)
    1.2 (1.1 to 1.3)
    1.2 (1.1 to 1.6)
    1.2 (1.1 to 1.3)
    Notes
    [9] - Baseline
    [10] - Baseline
    Statistical analysis title
    		 Angiotensin 1-7 pre/post
    Statistical analysis description
    Comparison of change in Angiotensin 1-7 with Candesartan versus Aliskiren use.
    Comparison groups
    Candesartan v Aliskiren v Candesartan v Aliskiren
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [11] - Wilcoxon signed-rank test was applied compare Angiotensin 1-7 levels before and after treatment with Candesartan and Aliskiren.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Patients were assessed for (S)AEs at every study visit, i.e. after the run-in phase (= at baseline visit), 1 week after study medication initiation, 4 weeks after initiation, 6 weeks after initiation and at the study end visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Aliskiren
    Reporting group description
    		 -

    Serious adverse events
    		 Candesartan Aliskiren
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Candesartan Aliskiren
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Study duration was relatively short (8 weeks) and the study was carried out in a stable cohort of patients with a chronic disease with study medications with long-standing regulatory approval. No events/laboratory changes requiring reporting were detected/documented.

    More information

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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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