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    Clinical Trial Results:
    A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy

    Summary
    EudraCT number
    		 2013-004429-97
    Trial protocol
    		 GB   NL   IT  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2019
    First version publication date
    30 Dec 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Adding text to “Limitations and Caveats” section

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-361-1157
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02291237
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    17 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2015
    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
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Israel: 14
    Country: Number of subjects enrolled
    United States: 109
    Worldwide total number of subjects
    172
    EEA total number of subjects
    47
    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)
    169
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Asia, Australia, Europe and North America. The first participant was screened on 05 February 2015. The last study visit occurred on 22 February 2017.

    Pre-assignment
    Screening details
    		 264 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eleclazine 30/3/6 mg
    Arm description
    		 Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eleclazine 3 mg
    Investigational medicinal product code
    Other name
    GS-6615
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eleclazine 3 mg tablet (s) administered orally for at least 24 weeks

    Investigational medicinal product name
    Eleclazine 6 mg
    Investigational medicinal product code
    Other name
    GS-6615
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eleclazine 6 mg tablet (s) administered orally on Day 1

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablet (s) administered orally for at least 24 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match eleclazine for at least 24 weeks

    Number of subjects in period 1
    		Eleclazine 30/3/6 mg Placebo
    Started
    86
    86
    Completed
    0
    0
    Not completed
    86
    86
         Withdrew Consent
    11
    11
         Adverse Event
    1
    3
         Investigator's Discretion
    -
    3
         Study Terminated by Sponsor
    72
    67
         Lost to follow-up
    -
    2
         Subject Required Prohibited Medication
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eleclazine 30/3/6 mg
    Reporting group description
    		 Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet (s) administered orally for at least 24 weeks

    Reporting group values
    		 Eleclazine 30/3/6 mg Placebo Total
    Number of subjects
    		 86 86 172
    Age categorical
    Units: Subjects
    Age continuous
    Safety Analysis Set: all randomized participants who received at least 1 dose of study drug.
    Units: years
        arithmetic mean (standard deviation)
    		 46 ( 11.7 ) 48 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 36 73
        Male
    		 49 50 99
    Race
    Units: Subjects
        White
    		 74 73 147
        Black or African American
    		 7 3 10
        Asian
    		 2 7 9
        Other
    		 2 1 3
        Not Permitted
    		 0 2 2
        American Indian or Alaska Native
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 11 9 20
        Not Hispanic or Latino
    		 75 75 150
        Not Permitted
    		 0 2 2
    Peak Oxygen Intake (VO2)
    Only 85 participants in the placebo arm with available data were analyzed.
    Units: mL/kg/min
        arithmetic mean (standard deviation)
    		 19.06 ( 4.853 ) 19.88 ( 4.645 ) -
    Minnesota Living With Heart Failure Questionnaire (MLHFQ)
    Units: Score
        arithmetic mean (standard deviation)
    		 40.22 ( 25.544 ) 38.80 ( 23.177 ) -
    Treadmill Exercise Time
    Only 84 participants in the placebo arm with available data were analyzed.
    Units: min
        arithmetic mean (standard deviation)
    		 12.88 ( 4.641 ) 13.60 ( 4.317 ) -

    End points

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    End points reporting groups
    Reporting group title
    Eleclazine 30/3/6 mg
    Reporting group description
    		 Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet (s) administered orally for at least 24 weeks

    Primary: Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24

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    End point title
    		 Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
    End point description
    Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    73
    68
    Units: mL/kg/min
        arithmetic mean (standard deviation)
    0.15 ( 4.312 )
    0.48 ( 4.143 )
    Statistical analysis title
    		 Change in Peak VO2- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).
    Comparison groups
    Placebo v Eleclazine 30/3/6 mg
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.416 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine - Placebo)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.87
         upper limit
    		 0.78
    Notes
    [1] - P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.

    Secondary: Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12

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    End point title
    		 Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    83
    78
    Units: mL/kg/min
        arithmetic mean (standard deviation)
    0.28 ( 4.028 )
    0.57 ( 4.314 )
    Statistical analysis title
    		 Change in Peak VO2- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).
    Comparison groups
    Eleclazine 30/3/6 mg v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.517 [2]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine − Placebo)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 0.85
    Notes
    [2] - P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.

    Secondary: Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24

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    End point title
    		 Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
    End point description
    The MLHFQ is a 21-item quality of life questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    74
    73
    Units: Score
        arithmetic mean (standard deviation)
    -4.05 ( 15.164 )
    -5.57 ( 14.345 )
    Statistical analysis title
    		 Change in MLHFQ- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline MLHFQ score, sex, and age (continuous).
    Comparison groups
    Eleclazine 30/3/6 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.513 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine - Placebo)
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.11
         upper limit
    		 6.19
    Notes
    [3] - P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.

    Secondary: Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12

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    End point title
    		 Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
    End point description
    The MLHFQ is a 21-item quality of life questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    85
    80
    Units: min
        arithmetic mean (standard deviation)
    -3.84 ( 15.654 )
    -3.40 ( 13.780 )
    Statistical analysis title
    		 Change in MLHFQ- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline MLHFQ score, time, sex, and age (continuous).
    Comparison groups
    Eleclazine 30/3/6 mg v Placebo
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.964 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine − Placebo)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.36
         upper limit
    		 4.56
    Notes
    [4] - P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.

    Secondary: Change in Treadmill Exercise Time From Baseline to Week 24

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    End point title
    		 Change in Treadmill Exercise Time From Baseline to Week 24
    End point description
    Treadmill exercise time is the time to peak exercise. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    73
    68
    Units: min
        arithmetic mean (standard deviation)
    0.27 ( 3.954 )
    0.24 ( 3.208 )
    Statistical analysis title
    		 Treadmill Exercise Time- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).
    Comparison groups
    Eleclazine 30/3/6 mg v Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.944 [5]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine - Placebo)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 1.1
    Notes
    [5] - P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline treadmill time as the covariate.

    Secondary: Change in Treadmill Exercise Time From Baseline to Week 12

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    End point title
    		 Change in Treadmill Exercise Time From Baseline to Week 12
    End point description
    Treadmill exercise time is the time to peak exercise. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Eleclazine 30/3/6 mg Placebo
    Number of subjects analysed
    83
    77
    Units: min
        arithmetic mean (standard deviation)
    0.48 ( 3.295 )
    0.38 ( 3.030 )
    Statistical analysis title
    		 Treadmill Exercise Time- Comparison of Groups
    Statistical analysis description
    The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous)
    Comparison groups
    Eleclazine 30/3/6 mg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.993 [6]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference(Eleclazine - Placebo)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.97
    Notes
    [6] - P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline treadmill time as the covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
    Adverse event reporting additional description
    Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Eleclazine 30/3/6 mg
    Reporting group description
    		 Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match eleclazine administered orally for at least 24 weeks

    Serious adverse events
    		 Eleclazine 30/3/6 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 86 (16.28%)
    16 / 86 (18.60%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    CARDIAC INDEX DECREASED
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CLAVICLE FRACTURE
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT FRACTURE
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL COMPLICATION
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCAPULA FRACTURE
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    HYPERTROPHIC CARDIOMYOPATHY
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST PAIN
         subjects affected / exposed
    2 / 86 (2.33%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 86 (0.00%)
    3 / 86 (3.49%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS BRADYCARDIA
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    SYNCOPE
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    CYSTITIS INTERSTITIAL
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETEROLITHIASIS
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    DEVICE RELATED INFECTION
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE INFECTION
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eleclazine 30/3/6 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 86 (67.44%)
    62 / 86 (72.09%)
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    9 / 86 (10.47%)
    11 / 86 (12.79%)
         occurrences all number
    10
    11
    VENTRICULAR TACHYCARDIA
         subjects affected / exposed
    2 / 86 (2.33%)
    5 / 86 (5.81%)
         occurrences all number
    3
    5
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 86 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    0
    7
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    12 / 86 (13.95%)
    14 / 86 (16.28%)
         occurrences all number
    14
    16
    HEADACHE
         subjects affected / exposed
    11 / 86 (12.79%)
    11 / 86 (12.79%)
         occurrences all number
    12
    12
    PRESYNCOPE
         subjects affected / exposed
    5 / 86 (5.81%)
    8 / 86 (9.30%)
         occurrences all number
    6
    10
    HYPOAESTHESIA
         subjects affected / exposed
    1 / 86 (1.16%)
    5 / 86 (5.81%)
         occurrences all number
    1
    5
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    11 / 86 (12.79%)
    9 / 86 (10.47%)
         occurrences all number
    13
    10
    FATIGUE
         subjects affected / exposed
    9 / 86 (10.47%)
    7 / 86 (8.14%)
         occurrences all number
    10
    8
    CHEST DISCOMFORT
         subjects affected / exposed
    6 / 86 (6.98%)
    3 / 86 (3.49%)
         occurrences all number
    7
    5
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    11 / 86 (12.79%)
    11 / 86 (12.79%)
         occurrences all number
    13
    13
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    16 / 86 (18.60%)
    8 / 86 (9.30%)
         occurrences all number
    17
    8
    COUGH
         subjects affected / exposed
    7 / 86 (8.14%)
    5 / 86 (5.81%)
         occurrences all number
    7
    5
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    5 / 86 (5.81%)
    2 / 86 (2.33%)
         occurrences all number
    5
    2
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    9 / 86 (10.47%)
    6 / 86 (6.98%)
         occurrences all number
    10
    9
    ARTHRALGIA
         subjects affected / exposed
    4 / 86 (4.65%)
    7 / 86 (8.14%)
         occurrences all number
    4
    7
    MUSCLE SPASMS
         subjects affected / exposed
    5 / 86 (5.81%)
    6 / 86 (6.98%)
         occurrences all number
    5
    6
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 86 (0.00%)
    5 / 86 (5.81%)
         occurrences all number
    0
    5
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    7 / 86 (8.14%)
    10 / 86 (11.63%)
         occurrences all number
    10
    11
    NASOPHARYNGITIS
         subjects affected / exposed
    5 / 86 (5.81%)
    11 / 86 (12.79%)
         occurrences all number
    6
    13
    INFLUENZA
         subjects affected / exposed
    3 / 86 (3.49%)
    5 / 86 (5.81%)
         occurrences all number
    3
    8
    BRONCHITIS
         subjects affected / exposed
    1 / 86 (1.16%)
    5 / 86 (5.81%)
         occurrences all number
    1
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2015
    1) Revision to Inclusion criterion to include adults with baseline Peak VO2 <80% of predicted (rather than <75%) 2) Revision to Predicted Peak VO2 equation 3) For adults screening under Protocol Amendment 1 (10 October 2014), the screening period will be extended to up to 60 days.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Dec 2016
    A letter was sent to all Study GS-US-361-1157 participating investigators on 18 November 2016, advising them of an important finding identified in a Phase 2 study in participants with ventricular tachycardia/ventricular fibrillation (VT/VF) and implantable cardioverter-defibrillator (ICDs) (Study GS-US-356-0101, TEMPO) in which the incidence rate of ICD shocks was higher in participants who received eleclazine compared with placebo. Another letter was sent to all Study GS-US-361-1157 participating investigators on 13 December 2016, advising them of Gilead’s decision to discontinue the development of eleclazine and terminate this study. In light of the data reviewed from Study GS-US-356-0101 and the subsequent discontinuation of the VT/VF development program, the totality of the data did not support continuation of the eleclazine development program for all other indications. This study was terminated prior to the end of the double-blind phase, and therefore no participants entered the open-label extension (OLE) period.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26915375
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