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    Clinical Trial Results:
    A Multicentre, Randomized, Double-blind Study to Evaluate and Compare the Efficacy and Safety of 8-week Treatment with Azilsartan Medoxomil and Amlodipine Besylate Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects

    Summary
    EudraCT number
    		 2022-002539-79
    Trial protocol
    		 PL  
    Global end of trial date
    19 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2026
    First version publication date
    14 May 2026
    Other versions
    Summary report(s)
    		 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-L05-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05385770
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, Taiwan, 22014
    Public contact
    Clinical Planning 7 Team, Celltrion Inc., 1099633284 82-32-850-5000, sanghee.byun@celltrion.com
    Scientific contact
    Clinical Planning 7 Team , Celltrion Inc., 1099633284 82-32-850-4176, sanghee.byun@celltrion.com
    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
    20 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate antihypertensive efficacy of a combination of Azilsartan medoxomil and Amlodipine besylate, in mild-to-moderate essential hypertensive subjects not adequately controlled by Azilsartan medoxomil monotherapy or Amlodipine besylate monotherapy
    Protection of trial subjects
    This study has been approved by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and has received a favorable opinion of the appropriate Ethics Committee, an independent organization that is responsible for making sure that the rights, safety and well-being of patients who take part in clinical research studies are protected. The approval by the by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the favourable opinion of the appropriate Ethics Committee should not be thought of as an encouragement for you to take part in this study. Even if you choose to take part in the study and sign the Informed consent forms, you are still free to withdraw from the study at any time without giving a reason. If you withdraw from the study, we will ask you to return for a post-study assessment to check your health. You may withdraw from the study at any time at your own request or may be withdrawn at any time at the discretion of the study doctor for safety, behavioral, or administrative reasons. Additional reasons for discontinuation can include, but are not limited to: death, adverse events, lack of efficacy of study treatment, pregnancy, sponsor determination, cardiac changes (QTcF), or your study doctor not being able to get in touch with you. The regulatory authorities supervising clinical trials and the responsible Ethics Committee (which reviews study safety procedures and reviews for ethics to ensure patients’ rights are not violated) also have the right to discontinue the study at any time, which will mean that you will be withdrawn from the study. Your identity, your personal health data and samples will be kept confidential. Without your consent, your personal data and samples cannot be used or shared with others. This is why you will not be able to take part in the study if you do not give your consent to use your personal data and samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2022
    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: 408
    Country: Number of subjects enrolled
    Korea, Republic of: 436
    Country: Number of subjects enrolled
    Taiwan: 46
    Worldwide total number of subjects
    890
    EEA total number of subjects
    408
    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)
    483
    From 65 to 84 years
    407
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicentre, randomized, double‑blind Phase 3 study in subjects with mild‑to‑moderate essential hypertension whose blood pressure was not adequately controlled on azilsartan medoxomil (40 or 80 mg) or amlodipine besylate (5 or 10 mg) monotherapy. Recruitment was conducted at participating clinical trial sites in Korea, Taiwan and Poland

    Pre-assignment
    Screening details
    		 Potential subjects attended an on‑site screening visit to assess eligibility against predefined inclusion/exclusion criteria and to obtain written informed consent. A screening period of up to approximately 2 weeks was used, including wash‑out of prior antihypertensive medications other than AZM or AML when applicable (up to 2 weeks).

    Period 1
    Period 1 title
    double-blind treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZM/AML 40/10 mg
    Arm description
    		 AZM 40 mg non responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 40/10 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 40/5 mg
    Arm description
    		 AZM 40 mg non responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 40/5 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM 40 mg
    Arm description
    		 AZM 40 mg non responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM 40 mg
    Investigational medicinal product code
    AZM
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 80/10 mg
    Arm description
    		 AZM 80 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 80/10 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 80/5 mg
    Arm description
    		 AZM 80 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 80/5 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM 80 mg
    Arm description
    		 AZM 80 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM 80 mg
    Investigational medicinal product code
    AZM
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 80/5 mg
    Arm description
    		 AML 5 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 80/5 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 40/5 mg
    Arm description
    		 AML 5 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 40/5 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AML 5 mg
    Arm description
    		 AML 5 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AML 5 mg
    Investigational medicinal product code
    AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 80/10 mg
    Arm description
    		 AML 10 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 80/10 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AZM/AML 40/10 mg
    Arm description
    		 AM 10 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZM/AML 40/10 mg
    Investigational medicinal product code
    AZM/AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Arm title
    		 AML 10 mg
    Arm description
    		 AML 10 mg non-responder group
    Arm type
    		 Experimental

    Investigational medicinal product name
    AML 10 mg
    Investigational medicinal product code
    AML
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, Once a day

    Number of subjects in period 1
    		AZM/AML 40/10 mg AZM/AML 40/5 mg AZM 40 mg AZM/AML 80/10 mg AZM/AML 80/5 mg AZM 80 mg AZM/AML 80/5 mg AZM/AML 40/5 mg AML 5 mg AZM/AML 80/10 mg AZM/AML 40/10 mg AML 10 mg
    Started
    75
    75
    75
    69
    70
    72
    80
    80
    81
    72
    70
    71
    Completed
    73
    74
    74
    66
    68
    68
    79
    78
    79
    70
    68
    71
    Not completed
    2
    1
    1
    3
    2
    4
    1
    2
    2
    2
    2
    0
         Not Dosed
    2
    -
    -
    2
    1
    2
    1
    1
    1
    1
    -
    -
         Not Evaluable Data for Primary efficacy
    -
    1
    1
    1
    1
    2
    -
    1
    1
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZM/AML 40/10 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM/AML 40/5 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM 40 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM/AML 80/10 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM/AML 80/5 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM 80 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM/AML 80/5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AZM/AML 40/5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AML 5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AZM/AML 80/10 mg
    Reporting group description
    		 AML 10 mg non-responder group

    Reporting group title
    AZM/AML 40/10 mg
    Reporting group description
    		 AM 10 mg non-responder group

    Reporting group title
    AML 10 mg
    Reporting group description
    		 AML 10 mg non-responder group

    Reporting group values
    		 AZM/AML 40/10 mg AZM/AML 40/5 mg AZM 40 mg AZM/AML 80/10 mg AZM/AML 80/5 mg AZM 80 mg AZM/AML 80/5 mg AZM/AML 40/5 mg AML 5 mg AZM/AML 80/10 mg AZM/AML 40/10 mg AML 10 mg Total
    Number of subjects
    		 75 75 75 69 70 72 80 80 81 72 70 71 890
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 45 47 39 34 34 39 55 42 49 35 38 26 483
        Adults (≥65 years)
    		 30 28 36 35 36 33 25 38 32 37 32 45 407
    Gender categorical
    Units: Subjects
        Female
    		 33 32 33 27 27 26 34 26 26 23 31 31 349
        Male
    		 42 43 42 42 43 46 46 54 55 49 39 40 541
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall, the majority of subjects were male (529/868, 60.9%) and Asian (477/868, 55.0%). Mean age was 60.4 years and most subjects were ≥45 years of age (772/868, 88.9%, including 398 subjects [45.9%] ≥65 years of age).

    Subject analysis set title
    Intent-to-Treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized were included in the ITT Set. Intent-to-Treat Set subjects were analyzed according to their randomized treatment.

    Subject analysis sets values
    		 Full Analysis Set Intent-to-Treat Set
    Number of subjects
    868
    890
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    470
    483
        Adults (≥65 years)
    398
    407
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    339
    349
        Male
    529
    541

    End points

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    End points reporting groups
    Reporting group title
    AZM/AML 40/10 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM/AML 40/5 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM 40 mg
    Reporting group description
    		 AZM 40 mg non responder group

    Reporting group title
    AZM/AML 80/10 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM/AML 80/5 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM 80 mg
    Reporting group description
    		 AZM 80 mg non-responder group

    Reporting group title
    AZM/AML 80/5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AZM/AML 40/5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AML 5 mg
    Reporting group description
    		 AML 5 mg non-responder group

    Reporting group title
    AZM/AML 80/10 mg
    Reporting group description
    		 AML 10 mg non-responder group

    Reporting group title
    AZM/AML 40/10 mg
    Reporting group description
    		 AM 10 mg non-responder group

    Reporting group title
    AML 10 mg
    Reporting group description
    		 AML 10 mg non-responder group

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall, the majority of subjects were male (529/868, 60.9%) and Asian (477/868, 55.0%). Mean age was 60.4 years and most subjects were ≥45 years of age (772/868, 88.9%, including 398 subjects [45.9%] ≥65 years of age).

    Subject analysis set title
    Intent-to-Treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized were included in the ITT Set. Intent-to-Treat Set subjects were analyzed according to their randomized treatment.

    Primary: change from baseline to Week 8 in msitSBP

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    End point title
    		 change from baseline to Week 8 in msitSBP
    End point description
    End point type
    Primary
    End point timeframe
    The primary outcome of interest was the change from baseline in msitSBP after 8 weeks of treatment.
    End point values
    		 AZM/AML 40/10 mg AZM/AML 40/5 mg AZM 40 mg AZM/AML 80/10 mg AZM/AML 80/5 mg AZM 80 mg AZM/AML 80/5 mg AZM/AML 40/5 mg AML 5 mg AZM/AML 80/10 mg AZM/AML 40/10 mg AML 10 mg
    Number of subjects analysed
    73
    74
    74
    66
    68
    68
    79
    78
    79
    70
    68
    71
    Units: mmHg
        least squares mean (standard deviation)
    -16.844 ( 1.6627 )
    -13.824 ( 1.6563 )
    -9.082 ( 1.6514 )
    -18.197 ( 1.8951 )
    -16.995 ( 1.7530 )
    -9.205 ( 1.8669 )
    -14.580 ( 1.4093 )
    -14.325 ( 1.3263 )
    -7.222 ( 1.4093 )
    -13.306 ( 1.5232 )
    -15.587 ( 1.5840 )
    -6.657 ( 1.5124 )
    Statistical analysis title
    		 the change from baseline in msitSBP after 8 weeks
    Statistical analysis description
    the change from baseline in msitSBP after 8 weeks of treatment.
    Comparison groups
    AZM 40 mg v AZM 80 mg v AML 5 mg v AML 10 mg
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during the treatment period after first administration of the investigational product (IP)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    AZM 40 mg non-responder group
    Reporting group description
    		 -

    Reporting group title
    AZM 80 mg non-responder group
    Reporting group description
    		 -

    Reporting group title
    AML 5 mg non responder group
    Reporting group description
    		 -

    Reporting group title
    AML 10 mg non-responder group
    Reporting group description
    		 -

    Serious adverse events
    		 AZM 40 mg non-responder group AZM 80 mg non-responder group AML 5 mg non responder group AML 10 mg non-responder group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 206 (0.00%)
    2 / 238 (0.84%)
    6 / 212 (2.83%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    1 / 238 (0.42%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    1 / 238 (0.42%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    0 / 238 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 AZM 40 mg non-responder group AZM 80 mg non-responder group AML 5 mg non responder group AML 10 mg non-responder group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 223 (2.69%)
    5 / 206 (2.43%)
    5 / 238 (2.10%)
    0 / 212 (0.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 206 (0.00%)
    5 / 238 (2.10%)
    0 / 212 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    6 / 223 (2.69%)
    3 / 206 (1.46%)
    0 / 238 (0.00%)
    0 / 212 (0.00%)
         occurrences all number
    6
    3
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 223 (0.00%)
    2 / 206 (0.97%)
    0 / 238 (0.00%)
    0 / 212 (0.00%)
         occurrences all number
    0
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2021
    The first version
    04 Nov 2021
    As per MFDS regulatory requirements Add discontinuation criteria Unify the term and clarify the expression, etc.
    25 Mar 2022
    As per TFDA regulatory requirements Changes in clinical laboratory analytes Typo correction, etc.
    27 Apr 2022
    As per TFDA regulatory requirements Update prohibited therapy and management after study completion for clarification. Update MedDRA version Typo correction, etc.
    07 Jun 2022
    Appendix 5 update (To specify COVID-19 confirmed subject participation guideline) Discrepancy, Typo correction, etc.
    27 Sep 2022
    Update of the inclusion/exclusion criteria Clarification of additional analyses including subgroup analyses if necessary Correction of discrepancy, typo and etc.
    28 Jul 2023
    Update of overall study design and plan description Update of the exclusion criteria Update of unnecessary description and additional clarification of Study procedures and assessments Update of the information of drug manufacturer Update to clarify the analysis populations of FAS Correction of discrepancy, typo etc.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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