Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02245529
Collaborator
(none)
982
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
982 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)
Study Start Date
:
Mar 1, 2005
Actual Primary Completion Date
:
Sep 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with benign prostatic hyperplasia (BPH)
|
Drug: Tamsulosin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of patients with adverse events [up to 6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02245529
Other Study ID Numbers:
- 527.64
First Posted:
Sep 19, 2014
Last Update Posted:
Sep 19, 2014
Last Verified:
Sep 1, 2014