Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

September 18, 2014 updated by: Boehringer Ingelheim

Secotex®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign Prostatic Hyperplasia in real clinical practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

811

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 treated with Secotex® in the daily clinical practice

Description

Inclusion Criteria:

  • Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH)
  • Patients with symptoms, that according to physician require medical treatment to improve quality of life
  • Patients could be naive to treatment or could be on treatment with other drugs but have not responded adequately to treatment

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign prostatic hyperplasia patients
Drug: Secotex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
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, 2004

Primary Completion (Actual)

November 1, 2004

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

  • 527.58

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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