Clincosm LogoSign in Get a demo

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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02245503
Collaborator
(none)
7,391
Enrollment

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
7391 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)
Study Start Date :
May 1, 2003
Actual Primary Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Benign prostatic hyperplasia

Patients with symptomatic BPH to whom ALNA was prescribed

Drug: Tamsulosin
Other Names:
  • ALNA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Collection of information on concomitant diseases [day 1]

    2. Collection of information on concomitant treatment [day 1]

    Secondary Outcome Measures

    1. Number of patients with adverse drug reactions [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:
    • 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

    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:
    NCT02245503
    Other Study ID Numbers:
    • 527.40
    First Posted:
    Sep 19, 2014
    Last Update Posted:
    Sep 19, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tamsulosin

    Study Results

    No Results Posted as of Sep 19, 2014