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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
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
Observational study model:
Other
Primary completion date:
2015-22-07
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Cancelled
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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