Last updated: 11/03/2018 15:17:33

Regulatory Nebilet PMSNebilet PMS

GSK study ID
113554
See study documents
Clinicaltrials.gov ID
NCT01077661
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: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebilet administered in Korean patients according to the prescribing information
Trial description: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of adverse events after Nebivolol administration

Timeframe: 3months, 6months

Secondary outcomes:

Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Nebivolol

Timeframe: 3 months, 6months

Interventions:
  • Drug: Nebivolol
    • Enrollment:
    743
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Hypertension, Heart Failure
    Product
    nebivolol
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to January 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:
    • Subjects with indication in the prescribing information
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:
    • Subjects with indication in the prescribing information
    • Subjects administrated Nebivolol by physician’s decision
    • Subjects with no contraindication according to the prescribing information

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 130-702
    Status
    Recruiting
    Contact us

    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
    2011-08-01

    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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