Status:

COMPLETED

Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Prostatic Hyperplasia

Eligibility:

MALE

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...

Eligibility Criteria

Inclusion

  • 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

  • Patients with known hypersensitivity to Tamsulosin, or any other component of the product
  • Patients with a history of orthostatic hypotension or severe liver failure

Key Trial Info

Start Date :

March 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

982 Patients enrolled

Trial Details

Trial ID

NCT02245529

Start Date

March 1 2005

Last Update

September 19 2014

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