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

Overview

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).

Full Title of Study: “Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2003

Interventions

  • Drug: Tamsulosin

Arms, Groups and Cohorts

  • Benign prostatic hyperplasia
    • Patients with symptomatic BPH to whom ALNA was prescribed

Clinical Trial Outcome Measures

Primary Measures

  • Collection of information on concomitant diseases
    • Time Frame: day 1
  • Collection of information on concomitant treatment
    • Time Frame: day 1

Secondary Measures

  • Number of patients with adverse drug reactions
    • Time Frame: up to 6 months

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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