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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.