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NCT02244346 Clinical Trial

Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Prostatic Hyperplasia Clinical Trial

Official title:
Secotex®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244346
Other study ID # 527.58
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date May 2004

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Ministry of Health
Study type Observational

Clinical Trial Summary

Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign Prostatic Hyperplasia in real clinical practice

Recruitment information / eligibility
Status Completed
Enrollment 811
Est. completion date
Est. primary completion date November 2004
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH)

- Patients with symptoms, that according to physician require medical treatment to improve quality of life

- Patients could be naive to treatment or could be on treatment with other drugs but have not responded adequately to treatment

Exclusion Criteria:

- Patients with known hypersensitivity to Tamsulosin, or any other component of the product

- Patients with a history of orthostatic hypotension or severe liver failure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Secotex®

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events up to 6 months No
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