Last updated: 02/03/2020 19:20:13

A post-marketing surveillance study of Duodart® (Dutasteride/Tamsulosin) in the treatment of Filipino patients with Benign Prostatic Hyperplasia (BPH)Duodart PMS

GSK study ID
116707
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A post-marketing surveillance study of Duodart® (Dutasteride/Tamsulosin) in the treatment of Filipino patients with Benign Prostatic Hyperplasia (BPH)
Trial description: This is a regulatory mandated post marketing surveillance study for Dutasteride/Tamsulosin (Duodart) to enrol 3000 patients prescribed with Duodart under normal clinical setting. The study duration is three years and it to collect safety data among local target population.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Safety data

Timeframe: 6 months

Secondary outcomes:

None

Timeframe: None

Interventions:
  • Drug: Duodart
    • Enrollment:
    0
    Primary completion date:
    2015-22-07
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride, dutasteride/tamsulosin, tamsulosin
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to July 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    18Years - 85Years
    Accepts healthy volunteers
    None
    • Adult patients (including elderly) with clinically diagnosed Benign Prostatic Hyperplasia (BPH),
    • As per recommendation of Duodart® (Dutasteride/Tamsulosin) prescribing information.
    • Women or males less than 18 years of age
    • Patients with known hypersensitivity to Dutasteride/Tamsulosin or any component of the preparation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adult patients (including elderly) with clinically diagnosed Benign Prostatic Hyperplasia (BPH),
    • As per recommendation of Duodart® (Dutasteride/Tamsulosin) prescribing information.
    Exclusion criteria:
    • Women or males less than 18 years of age
    • Patients with known hypersensitivity to Dutasteride/Tamsulosin or any component of the preparation.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    Other
    Actual primary completion date
    2015-22-07
    Actual study completion date
    2015-22-07

    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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