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

September 18, 2014 updated by: Boehringer Ingelheim

Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with BPH recruited at urologist offices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign prostatic hyperplasia
Patients with symptomatic BPH to whom ALNA was prescribed
Drug: Tamsulosin
Other Names:
  • ALNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection of information on concomitant diseases
Time Frame: day 1
day 1
Collection of information on concomitant treatment
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse drug reactions
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527.40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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