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    Clinical Trial Results:
    Efficacy and safety of chlorthalidone 25 mg in hypertensive patients.

    Summary
    EudraCT number
    		 2016-001809-16
    Trial protocol
    		 GR  
    Global end of trial date
    20 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2021
    First version publication date
    19 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Unidone-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA
    Sponsor organisation address
    14th Km National Road 1, Kifissia, Greece, 14564
    Public contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 30 2108072512374, soumelas@uni-pharma.gr
    Scientific contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 30 2108072512374, soumelas@uni-pharma.gr
    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
    01 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to address the BP lowering effect of chlorthalidone 25 mg in essential hypertensive patients. In parallel, safety following chlorthalidone administration will be evaluated in the patients that will be enrolled in the study. In specific: Primary efficacy end-points 1.Changes in Office BP at 4 and 12 weeks. 2.Patients with controlled hypertension at 12 weeks. Primary safety end-points 1.Changes in renal function by means of serum creatinine, estimated glomerular filtration rate (eGFR) and albuminuria at 4 and 12 weeks. 2.Changes in serum sodium, potassium and calcium levels at 4 and 12 weeks. 3.Changes in glycemic, lipid profile as well as uric acid levels at 4 and 12 weeks. 4.Hypotension episodes during follow-up. 5.Hospitalization for cardiovascular or any other systemic disease during follow-up.
    Protection of trial subjects
    Νo specific measures applied
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    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
    Greece: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    18
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was admitted to the study on 04.04.2017 and the last on 20.03.2018. A total of n = 44 hypertensive patients were recruited, who completed the study in 1 center: Hypertension Unit, First Cardiology Clinic University of Athens, Hippokration Hospital, Athens, Greece

    Pre-assignment
    Screening details
    		 44 patients (18 <Age≤75 years old) with untreated or treated uncontrolled essential hypertension characterized by office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg. Potential fertile women enrolled underwent a pregnancy test that excluded any possibility of present pregnancy and confirmed to use a safe contraceptive method.

    Period 1
    Period 1 title
    Second visit
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Examination at 12 weeks of therapy
    Arm description
    		 Patients will be examined in this final study visit and office systolic/diastolic BP will be evaluated along with metabolic profile determination. The percentage of patients with hypertension control (office BP<140/90 mmHg) will be estimated. During the week before the visit a drug intake diary will be kept by the patient.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unidone 25mg tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Same as First visit

    Number of subjects in period 1
    		Examination at 12 weeks of therapy
    Started
    44
    Completed
    44
    Period 2
    Period 2 title
    Baseline period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Chlorthalidone 25mg
    Arm description
    		 After subjects have given their informed consent to participate to the study, they will be examined at baseline and those with office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg using an automatic BP Monitor (Omron Healthcare, Inc., Bannockburn, Illinois, USA) will enter into the study in absence of any exclusion criteria. If office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg is confirmed by ambulatory daytime systolic BP≥135 mmHg and/or daytime diastolic BP≥85 mmHg, using an ambulatory BP system (Spacelabs Healthcare, Inc., Issaquah, Washington, USA), therapy with chlorthalidone 25 mg once daily will be initiated. Moreover, before initiation of chlorthalidone therapy blood samples will be drawn for estimation of renal function and metabolic profile.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unidone 25mg tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Chlorthalidone 25 mg tablets once daily

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the baseline. This was assigned by mistake.
    Number of subjects in period 2
    		Chlorthalidone 25mg
    Started
    44
    Completed
    44
    Period 3
    Period 3 title
    First visit
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Examination at 4 weeks of therapy
    Arm description
    		 Patients will be examined and office systolic/diastolic BP will be evaluated. In 1 out 4 consecutive patients ambulatory BP will be also evaluated on all time points of the study along with metabolic profile determination. If office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg step up of therapy with chlorthalidone 50 mg is in the discretion of the investigators. During the week before the visit a drug intake diary will be kept by the patient.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unidone 25mg tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Chlorthalidone 25 mg tablets once daily. If office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg step up of therapy with chlorthalidone 50 mg is in the discretion of the investigators.

    Number of subjects in period 3
    		Examination at 4 weeks of therapy
    Started
    44
    Completed
    44

    Baseline characteristics

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

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 44 44
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 26 26
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62 ± 9 -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Examination at 12 weeks of therapy
    Reporting group description
    		 Patients will be examined in this final study visit and office systolic/diastolic BP will be evaluated along with metabolic profile determination. The percentage of patients with hypertension control (office BP<140/90 mmHg) will be estimated. During the week before the visit a drug intake diary will be kept by the patient.
    Reporting group title
    Chlorthalidone 25mg
    Reporting group description
    		 After subjects have given their informed consent to participate to the study, they will be examined at baseline and those with office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg using an automatic BP Monitor (Omron Healthcare, Inc., Bannockburn, Illinois, USA) will enter into the study in absence of any exclusion criteria. If office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg is confirmed by ambulatory daytime systolic BP≥135 mmHg and/or daytime diastolic BP≥85 mmHg, using an ambulatory BP system (Spacelabs Healthcare, Inc., Issaquah, Washington, USA), therapy with chlorthalidone 25 mg once daily will be initiated. Moreover, before initiation of chlorthalidone therapy blood samples will be drawn for estimation of renal function and metabolic profile.
    Reporting group title
    Examination at 4 weeks of therapy
    Reporting group description
    		 Patients will be examined and office systolic/diastolic BP will be evaluated. In 1 out 4 consecutive patients ambulatory BP will be also evaluated on all time points of the study along with metabolic profile determination. If office systolic BP ≥140 mmHg and/or office diastolic BP≥90 mmHg step up of therapy with chlorthalidone 50 mg is in the discretion of the investigators. During the week before the visit a drug intake diary will be kept by the patient.

    Primary: Changes in Office BP

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    End point title
    		 Changes in Office BP [1]
    End point description
    Changes in Office BP at 4 weeks
    End point type
    Primary
    End point timeframe
    4 weeks
    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: N/A
    End point values
    		 Examination at 4 weeks of therapy
    Number of subjects analysed
    44
    Units: mmHg
        arithmetic mean (standard deviation)
    138 ± 15
    No statistical analyses for this end point

    Primary: Changes in Office BP

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    End point title
    		 Changes in Office BP [2]
    End point description
    Changes in Office BP at 12 weeks
    End point type
    Primary
    End point timeframe
    12 weeks
    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: N/A
    End point values
    		 Examination at 12 weeks of therapy
    Number of subjects analysed
    44
    Units: mmHg
        arithmetic mean (standard deviation)
    134 ± 13
    No statistical analyses for this end point

    Primary: Patients with controlled hypertension

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    End point title
    		 Patients with controlled hypertension [3]
    End point description
    Patients with controlled hypertension at 12 weeks
    End point type
    Primary
    End point timeframe
    12 weeks
    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: N/A
    End point values
    		 Examination at 12 weeks of therapy
    Number of subjects analysed
    44
    Units: percent
        number (not applicable)
    81.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    End of trial
    Reporting group description
    		 AEs reported after 12 weeks of treatment

    Serious adverse events
    		 End of trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 End of trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Cardiac disorders
    Hypotension
    Additional description: There was 1 episode of hypotension without syncope during follow-up which was attributed to dehydration of the patient.
         subjects affected / exposed [1]
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
    Additional description: In 1 patient, diarrhoea occurred during the first 4 weeks of treatment which was treated symptomatically.
         subjects affected / exposed [2]
    1 / 1 (100.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Glomerular filtration rate increased
    Additional description: In 1 patient there was an increase in glomerular filtration rate above 30% of baseline. By halving the dose of chlorthalidone and hydration, renal function was improved by the rate to baseline levels and treatment was continued
         subjects affected / exposed [3]
    1 / 1 (100.00%)
         occurrences all number
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The reporting group is referring to the end of the trial and to the total AEs reported.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The reporting group is referring to the end of the trial and to the total AEs reported.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The reporting group is referring to the end of the trial and to the total AEs reported.

    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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