Last updated: 05/24/2019 13:10:15
Burden of disease and health economic analysis of patients with Benign Prostatic Hyperplasia (BPH) in Brazil
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Discontinued
Discontinued
Trial overview
Official title: Burden of disease and health economic analysis of patients with Benign Prostatic Hyperplasia (BPH) in Brazil
Trial description: This is an observational medical chart review of patients with BPH that aims to investigate the epidemiological profile, diagnostic and therapeutic approach and use of healthcare resources by patients with BPH in Brazil.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Total cost of BPH treatment in Brazil
Timeframe: Last 03 years of HPB treatment
Secondary outcomes:
Epidemiologic profile
Timeframe: Last 03 years of HPB treatment
Interventions:
Other: Not Applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2015-30-11
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
March 2012 to November 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
Not applicable
- Patients with age ≥ 50 years with diagnosis of Benign Prostatic Hyperplasia N40 (International Classification of Diseases version 10)
- Diagnosed and followed for at least 3 years
- Patients with diagnose of prostatic cancer
- Patients with diagnose of bladder cancer
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with age ≥ 50 years with diagnosis of Benign Prostatic Hyperplasia N40 (International Classification of Diseases version 10)
- Diagnosed and followed for at least 3 years
- Patients from Brazilian Public Health System (SUS) or private clinics
- Patients must have medical visits scheduled within 12 weeks
Exclusion criteria:
- Patients with diagnose of prostatic cancer
- Patients with diagnose of bladder cancer
- Patients with lower urinary tract symptoms (LUTS) not associated with Benign Prostatic Hyperplasia
Trial location(s)
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20 551-030
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20020022
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05403-900
Status
Study Complete
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
Discontinued
Actual primary completion date
2015-30-11
Actual study completion date
2015-30-11
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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