Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

NCT02245529 | Completed

• 1 other identifier: 527.64
• Study Type: observational
• Target: 982
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  up to 6 months

Study Arms (1)

Patients with benign prostatic hyperplasia (BPH)

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

Also known as: Secotex ®

Patients with benign prostatic hyperplasia (BPH)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) who require medical treatment to improve their quality of life

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: March 1, 2005
• Primary Completion: September 1, 2005
• Last Updated: September 19, 2014

Record last verified: 2014-09