Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

Boehringer Ingelheim

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: Tamsulosin

Study type: Observational

Funder types: Industry

Identifiers

NCT02245529

527.64

Details and patient eligibility

About

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

Enrollment: 982 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

982 participants in 1 patient group

Patients with benign prostatic hyperplasia (BPH)

Treatment:

Drug: Tamsulosin