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NCT02245529 Clinical Trial

Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

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 NCT02245529
Other study ID # 527.64
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date March 2005

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

The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice

Recruitment information / eligibility
Status Completed
Enrollment 982
Est. completion date
Est. primary completion date September 2005
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) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information

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:
• Tamsulosin

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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