Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

NCT02245555 | Completed

• 1 other identifier: 527.73
• Study Type: observational
• Target: 1,060
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to describe Tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  up to 21 months

Study Arms (1)

Patients with benign prostatic hyperplasia

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

Also known as: Secotex®

Patients with benign prostatic hyperplasia

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with benign prostatic hyperplasia (BPH), who require pharmacological treatment

You may qualify if:

• Patients older than 21 years old diagnosed with benign prostatic hyperplasia (BPH), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. The study will include naïve patients and patients not responding to previous therapy who receive Secotex as alternative or complementary treatment. The decision to treat a patient with Tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following Secotex (Tamsulosin) prescription information

You may not qualify if:

• Patients with known hypersensitivity to Tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded

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: April 1, 2006
• Primary Completion: December 1, 2007
• Last Updated: September 19, 2014

Record last verified: 2014-09