NCT02245503

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,391

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
11 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 18, 2014

Last Update Submit

September 18, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Collection of information on concomitant diseases

    day 1

  • Collection of information on concomitant treatment

    day 1

Secondary Outcomes (1)

  • Number of patients with adverse drug reactions

    up to 6 months

Study Arms (1)

Benign prostatic hyperplasia

Patients with symptomatic BPH to whom ALNA was prescribed

Drug: Tamsulosin

Interventions

TamsulosinDRUG
Also known as: ALNA
Benign prostatic hyperplasia

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with BPH recruited at urologist offices

You may qualify if:

  • Indication for the treatment with ALNA according to its summary of product characteristics (SPC)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 19, 2014

Study Start

May 1, 2003

Primary Completion

October 1, 2003

Last Updated

September 19, 2014

Record last verified: 2014-09