Last updated: 11/07/2018 02:53:13

An Observational Study For AmbrisentanVOLT

GSK study ID
110094
See study documents
Clinicaltrials.gov ID
NCT00679224
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
Trial description: The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

safety monitoring

Timeframe: N/A

Secondary outcomes:

safety monitoring

Timeframe: N/A

Interventions:
  • Drug: ambrisentan
    • Enrollment:
    800
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Vachiery JL, Hoeper M, Peacock A, Sitbon O, Cheli M, Church C, Olsson KM, Palazzini M, Waterhouse B, Langley J, Galie N. Ambrisentan use for pulmonary arterial hypertension (PAH) in a post-authorisation drug registry: The VOLibris Tracking study. J Heart Lung Transplant. 2017;36(4):399-406.
    Medical condition
    Hypertension, Pulmonary
    Product
    ambrisentan
    Collaborators
    GSK
    Study date(s)
    June 2008 to July 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Strasbourg, France, 67098
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Luebeck, Schleswig-Holstein, Germany, 23538
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Voula / Athens, Greece, 166 73
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Loewenstein, Baden-Wuerttemberg, Germany, 74245
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V5Z 1M9
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Newcastle upon Tyne, United Kingdom, NE7 7DN
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 113 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-12-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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