Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02245555
Collaborator
(none)
1,060
Study Details
Study Description
Brief Summary
Study to describe Tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
1060 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study About the Use of Tamsulosin in Patients With Benign Prostatic Hyperplasia
Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Dec 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with benign prostatic hyperplasia
|
Drug: Tamsulosin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of patients with adverse events [up to 21 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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:
NCT02245555
Other Study ID Numbers:
- 527.73
First Posted:
Sep 19, 2014
Last Update Posted:
Sep 19, 2014
Last Verified:
Sep 1, 2014