Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (BPH)

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin

• Registration Number: NCT02245503
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objectives of this post marketing surveillance study were to document the comorbidity and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-10
• Status Verified: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7391

Inclusion Criteria

• Indication for the treatment with ALNA according to its summary of product characteristics (SPC)

Exclusion Criteria

• Patients fulfilling one of the general or specific contraindications listed in the ALNA SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency cannot be included in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign prostatic hyperplasia	Tamsulosin	Patients with symptomatic BPH to whom ALNA was prescribed

Primary Outcome Measures

Name	Time	Method
Collection of information on concomitant diseases	day 1
Collection of information on concomitant treatment	day 1

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reactions	up to 6 months