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    Clinical Trial Results:
    A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension

    Summary
    EudraCT number
    2010-018322-40
    Trial protocol
    FR   BE   NL   ES   IT  
    Global end of trial date
    02 Feb 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jun 2017
    First version publication date
    17 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-066A301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01431716
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Actelion Pharmaceuticals Ltd
    Sponsor organisation address
    Gewerbestrasse 16, Allschwil, Switzerland, 4123
    Public contact
    Global Scientific Information, Actelion Pharmaceuticals Ltd, medinfo@actelion.com
    Scientific contact
    Global Scientific Information, Actelion Pharmaceuticals Ltd, medinfo@actelion.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
    26 Mar 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan® to EFI in patients with pulmonary arterial hypertension (PAH). To evaluate the safety and tolerability of switching from Flolan® to EFI in patients with PAH.
    Protection of trial subjects
    The clinical trial was designed and conducted in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and with the ethical principles laid down in the Declaration of Helsinki. The protocol, the amendments and any material provided to the patient (such as a patient information sheet or description of the study used to obtain informed consent) were reviewed and approved by the appropriate IEC before the study was started. The investigator ensured that this study was conducted in full compliance with the principles of the ‘Declaration of Helsinki’ and its amendments, and with the laws and regulations of the country in which the clinical research was conducted. A copy of the Declaration of Helsinki and International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) Guidelines was provided to each investigational site. Written informed consent was obtained from each individual participating in the study prior to any study procedure and after adequate explanation of the objectives, methods, and potential hazards of the study. During the 90-day treatment period, there were visits to the clinic on week 1, 4, and 12, and phone calls from the clinic to the patient on weeks 2, 3, 6, 8, 10 and 16, and on Day 91.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Mar 2011
    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
    Spain: 2
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Netherlands: 4
    Worldwide total number of subjects
    41
    EEA total number of subjects
    33
    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)
    38
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were enrolled at eight centers in the European Union and Canada. First patient, first visit was 15 March 2011 and last patient, last visit was 2 February 2012.

    Pre-assignment
    Screening details
    Patients must have PAH and have been treated with Flolan for at least 12 months and on a stable dose for at least 3 months prior to enrollment. There was a screening period of up to 14 days.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Epoprostenol for injection (EFI/ACT-385781A)
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Epoprostenol for Injection
    Investigational medicinal product code
    ACT-385781A
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous intravenous

    Number of subjects in period 1
    Epoprostenol for injection (EFI/ACT-385781A)
    Started
    41
    Completed
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    Treatment

    Reporting group values
    Overall study Total
    Number of subjects
    41 41
    Age categorical
    Age categorical description
    Units: participants
        <=18 years
    0 0
        Between 18 and 65 years
    38 38
        >=65 years
    3 3
    Age continuous
    Age continuous description
    Units: years
        median (full range (min-max))
    46 (23 to 78) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    30 30
        Male
    11 11
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    18 18
        Black
    2 2
        Asian
    1 1
        Not Collected
    20 20
    Region of Enrollment
    Units: Subjects
        France
    20 20
        Canada
    8 8
        Spain
    2 2
        Belgium
    5 5
        Netherlands
    4 4
        Italy
    2 2
    Subject analysis sets

    Subject analysis set title
    All-treated set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Patients with at least one dose of study medication

    Subject analysis set title
    Per-protocol set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Treated patients who had a pulmonary vascular resistance (PVR) value at baseline and at end of treatment (EOT) and who did not deviate from the protocol in a way that might have affected the evaluation of PVR. This set was used for a supportive analysis of PVR only.

    Subject analysis sets values
    All-treated set Per-protocol set
    Number of subjects
    41
    27
    Age categorical
    Age categorical description
    Units: participants
        <=18 years
    0
        Between 18 and 65 years
    38
        >=65 years
    3
    Age continuous
    Age continuous description
    Units: years
        median (full range (min-max))
    46 (23 to 78)
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    30
        Male
    11
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    18
        Black
    2
        Asian
    1
        Not Collected
    20
    Region of Enrollment
    Units: Subjects
        France
    20
    14
        Canada
    8
    7
        Spain
    2
    1
        Belgium
    5
    2
        Netherlands
    4
    1
        Italy
    2
    2

    End points

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    End points reporting groups
    Reporting group title
    Epoprostenol for injection (EFI/ACT-385781A)
    Reporting group description
    -

    Subject analysis set title
    All-treated set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Patients with at least one dose of study medication

    Subject analysis set title
    Per-protocol set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Treated patients who had a pulmonary vascular resistance (PVR) value at baseline and at end of treatment (EOT) and who did not deviate from the protocol in a way that might have affected the evaluation of PVR. This set was used for a supportive analysis of PVR only.

    Primary: Not applicable

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    End point title
    Not applicable [1]
    End point description
    No primary endpoint was defined.As it is an exploratory study, all efficacy endpoints were considered as exploratory endpoints
    End point type
    Primary
    End point timeframe
    Not applicable
    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: This was an exploratory study. No statistical analysis has been specified.
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    0 [2]
    Units: Not applicable
    Notes
    [2] - Not applicable
    No statistical analyses for this end point

    Other pre-specified: Change in PVR from baseline to EOT.

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    End point title
    Change in PVR from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A) All-treated set Per-protocol set
    Number of subjects analysed
    36
    36
    27
    Units: dyn/sec/cm^5
    arithmetic mean (standard deviation)
        Baseline
    595.7 ± 237.14
    595.7 ± 237.14
    587.61 ± 240.71
        End of treatment
    587.66 ± 248.44
    587.66 ± 248.44
    602.12 ± 247.99
        Change from baseliine
    -8.04 ± 116.83
    -8.04 ± 116.83
    14.52 ± 111.27
    No statistical analyses for this end point

    Other pre-specified: Change in total pulmonary resistance from baseline to EOT.

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    End point title
    Change in total pulmonary resistance from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    41
    Units: dyn/sec/cm^5
    arithmetic mean (standard deviation)
        Baseline
    752.44 ± 260.91
        End of treatment
    757.51 ± 296.82
        Change from baseline
    5.07 ± 128.89
    No statistical analyses for this end point

    Other pre-specified: Change in mean pulmonary arterial pressure from baseline to EOT.

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    End point title
    Change in mean pulmonary arterial pressure from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    41
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    51.9 ± 11.5
        End of treatment
    51.7 ± 12.8
        Change from baseline
    -0.2 ± 7
    No statistical analyses for this end point

    Other pre-specified: Change in mean right atrial pressure from baseline to EOT.

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    End point title
    Change in mean right atrial pressure from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    41
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    7.9 ± 4.6
        End of treatment
    7.1 ± 4.6
        Change from baseline
    -0.8 ± 3.6
    No statistical analyses for this end point

    Other pre-specified: Change in pulmonary capillary wedge pressure from baseline to EOT.

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    End point title
    Change in pulmonary capillary wedge pressure from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    36
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    10.3 ± 3.8
        End of treatment
    10.1 ± 4.3
        Change from baseline
    -0.2 ± 3.4
    No statistical analyses for this end point

    Other pre-specified: Change in mean cardiac index from baseline to EOT.

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    End point title
    Change in mean cardiac index from baseline to EOT.
    End point description
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    41
    Units: L/min/m^2
    arithmetic mean (standard deviation)
        Baseline
    3.34 ± 0.71
        End of treatment
    3.38 ± 0.81
        Change from baseline
    0.04 ± 0.5
    No statistical analyses for this end point

    Other pre-specified: Change in 6-minute walk distance (6MWD) from baseline to EOT.

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    End point title
    Change in 6-minute walk distance (6MWD) from baseline to EOT.
    End point description
    The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    40
    Units: meter
    arithmetic mean (standard deviation)
        Baseline
    498.1 ± 86
        End of treatment
    492.8 ± 81.6
        Change from baseline
    -5.3 ± 29.1
    No statistical analyses for this end point

    Other pre-specified: Change in Borg dyspnea score from baseline to EOT.

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    End point title
    Change in Borg dyspnea score from baseline to EOT.
    End point description
    The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled "extremely severe," or "the worst possible dyspnea imaginable."
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    40
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4 ± 2.1
        End of treatment
    3.3 ± 2.1
        Change from baseline
    -0.7 ± 1.1
    No statistical analyses for this end point

    Other pre-specified: Number of participants with Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) from baseline to EOT.

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    End point title
    Number of participants with Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) from baseline to EOT.
    End point description
    NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    40
    Units: participants
        Improved
    1
        No change
    35
        Worsened
    4
    No statistical analyses for this end point

    Other pre-specified: Change in N-terminal pro-B-type natriuretic peptide (NT proBNP) from baseline to EOT.

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    End point title
    Change in N-terminal pro-B-type natriuretic peptide (NT proBNP) from baseline to EOT.
    End point description
    Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    36
    Units: ng/L
    arithmetic mean (standard deviation)
        Baseline
    599.97 ± 1164.21
        End of treatment
    613.56 ± 1155.9
        Change from baseline
    13.58 ± 318.58
    No statistical analyses for this end point

    Other pre-specified: Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.

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    End point title
    Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.
    End point description
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    38
    Units: units on a scale
    median (confidence interval 95%)
        Baseline
    77.78 (74.07 to 83.33)
        End of treatment
    77.78 (72.22 to 83.33)
        Change from baseline
    0 (-5.56 to 0)
    No statistical analyses for this end point

    Other pre-specified: Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.

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    End point title
    Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.
    End point description
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    38
    Units: units on a scale
    median (confidence interval 95%)
        Baseline
    52.78 (44.44 to 61.11)
        End of treatment
    66.67 (55.56 to 72.22)
        Change from Baseline
    16.67 (5.56 to 22.22)
    No statistical analyses for this end point

    Other pre-specified: Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.

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    End point title
    Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) from Baseline to EOT.
    End point description
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    38
    Units: units on a scale
    median (confidence interval 95%)
        Baseline
    72.92 (61.11 to 84.72)
        End of treatment
    76.39 (68.06 to 84.72)
        Change from baseline
    2.08 (0 to 8.33)
    No statistical analyses for this end point

    Other pre-specified: Number of participants with adverse events leading to discontinuation of study drug from baseline to EOT.

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    End point title
    Number of participants with adverse events leading to discontinuation of study drug from baseline to EOT.
    End point description
    Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.
    End point type
    Other pre-specified
    End point timeframe
    Approximately 3 months
    End point values
    Epoprostenol for injection (EFI/ACT-385781A)
    Number of subjects analysed
    41
    Units: participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) that occurred from the start of study treatment until 24 h after the end of study treatment were recorded. In addition, all serious AEs that occurred up to 30 days after the end of study treatment were also recorded.
    Adverse event reporting additional description
    All treated set
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    EFI/ACT-385781A
    Reporting group description
    EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.

    Serious adverse events
    EFI/ACT-385781A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 41 (17.07%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Right ventricular failure
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Device connection issue
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device damage
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
    Additional description: pseudomonas
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    EFI/ACT-385781A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 41 (78.05%)
    Vascular disorders
    FLUSHING
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    5
    Cardiac disorders
    PALPITATIONS
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    EPISTAXIS
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    DYSPNOEA
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Nervous system disorders
    HEADACHE
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    13
    Musculoskeletal and connective tissue disorders
    PAIN IN JAW
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    6
    PAIN IN EXTREMITY
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Infections and infestations
    NASOPHARYNGITIS
    alternative dictionary used: MedDRA 14
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    7

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2010
    1. A modification to the formulation of the study drug and resulting changes to its stability, availability and its name were described: – Changes in study drug excipients were described. In contrast to the previous formulation (EFI1), this new formulation (EFI2) has not been approved by FDA. – Instructions for study drug packaging, and preparation, handling and storage of the study drug solution were updated accordingly. – The drug name was changed to Epoprostenol for injection (EFI). – An additional dose strength of 0.5 mg was added. 2. The numbers of participating countries and of patients to be enrolled were increased from 20 to 25–35 patients. 3. Changes were made in the core patient information and informed consent form. 4. Some editorial changes were made for clarification and to correct typing errors. 5. The authors of the protocol and the sponsor’s contact details and signatories were changed.

    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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