Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia
- Registration Number
- NCT02245529
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 982
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with benign prostatic hyperplasia (BPH) Tamsulosin -
- Primary Outcome Measures
Name Time Method Number of patients with adverse events up to 6 months
- Secondary Outcome Measures
Name Time Method