Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Local, Single-Centre, Extension, Open Label Access Study, to Provide Sildenafil Therapy for Subjects who Completed A1481156 Study and are Judged by the Investigator to Derive Clinical Benefit From Continued Treatment With Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation

    Summary
    EudraCT number
    		 2019-001552-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2019
    First version publication date
    24 Aug 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A1481307
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide sildenafil citrate therapy to the subjects who completed study A1481156 for the treatment of pulmonary arterial hypertension (PAH) in Russian Federation where Revatio has not been approved by the Ministry of Healthcare and Social Development for subjects with PAH, is not commercially available, is not reimbursed through drug reimbursement program and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil citrate.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2012
    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
    Russian Federation: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    0
    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)
    1
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted between 19 November 2012 and 01 March 2019 in Russian Federation. Total of 7 subjects were enrolled, who had completed A1481156 study.

    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
    		 Sildenafil Citrate
    Arm description
    		 Subjects who completed Study A1481156 received sildenafil citrate as assigned by the investigator for the treatment of PAH until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation (approximately up to 76 months)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sildenafil Citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged greater than or equals to (>=) 18 years and pediatric subjects (aged 1-17 years) with body weight greater than (>) 20 kilogram (kg) received 20 milligram (mg) sildenafil tablet orally three times a day (TID) and pediatric subjects with body weight less than or equals to (<=) 20 kg received 10 mg sildenafil tablet orally TID until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation.

    Number of subjects in period 1
    		Sildenafil Citrate
    Started
    7
    Completed
    5
    Not completed
    2
         Consent withdrawn by subject
    1
         Noncompliance
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sildenafil Citrate
    Reporting group description
    		 Subjects who completed Study A1481156 received sildenafil citrate as assigned by the investigator for the treatment of PAH until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation (approximately up to 76 months)

    Reporting group values
    		 Sildenafil Citrate Total
    Number of subjects
    		 7 7
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 1 1
        Adolescents (12-17 years)
    		 3 3
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sildenafil Citrate
    Reporting group description
    		 Subjects who completed Study A1481156 received sildenafil citrate as assigned by the investigator for the treatment of PAH until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation (approximately up to 76 months)

    Primary: Subjects With Clinical Benefit on Usage of Continued Sildenafil Citrate

    		 Close Top of page
    End point title
    		 Subjects With Clinical Benefit on Usage of Continued Sildenafil Citrate [1]
    End point description
    Sildenafil citrate therapy was provided to subjects for the treatment of PAH and were judged by the investigator to derive clinical benefit from continued treatment with the study drug. It was planned to be supplied until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation.
    End point type
    Primary
    End point timeframe
    Up to 76 months
    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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 Sildenafil Citrate
    Number of subjects analysed
    0 [2]
    Units: subjects
    Notes
    [2] - No efficacy analysis was performed for this study.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 76 months
    Adverse event reporting additional description
    Same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both the events. Version was not captured, here 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Sildenafil Citrate
    Reporting group description
    		 Subjects who completed Study A1481156 received sildenafil citrate as assigned by the investigator for the treatment of PAH until the subjects gained access to reimbursed sildenafil citrate through drug reimbursement program of the Ministry of Healthcare and Social Development of Russian Federation (approximately up to 76 months)

    Serious adverse events
    		 Sildenafil Citrate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sildenafil Citrate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    Pregnancy, puerperium and perinatal conditions
    MATERNAL EXPOSURE DURING PREGNANCY
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Nov 2011
    Changes in sildenafil dose were made based on the data monitoring committee (DMC) recommendations following the DMC meeting on 04 August 2011.
    14 Mar 2013
    Changes to the safety language were made based on February 2013 updates to the CT02 protocol template.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 02:12:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA