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NCT02245503 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02245503
Other study ID # 527.40
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date May 2003

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 7391
Est. completion date
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tamsulosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Collection of information on concomitant diseases day 1 No
Primary Collection of information on concomitant treatment day 1 No
Secondary Number of patients with adverse drug reactions up to 6 months No
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