NCT02244346

Brief Summary

Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign Prostatic Hyperplasia in real clinical practice

Trial Health

100
On Track

Trial Health Score

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

Enrollment
811

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, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
9.9 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

6 months

First QC Date

September 18, 2014

Last Update Submit

September 18, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    up to 6 months

Study Arms (1)

Benign prostatic hyperplasia patients

Drug: Secotex®

Interventions

Secotex®DRUG
Benign prostatic hyperplasia patients

Eligibility Criteria

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

Patients treated with Secotex® in the daily clinical practice

You may qualify if:

  • Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH)
  • Patients with symptoms, that according to physician require medical treatment to improve quality of life
  • Patients could be naive to treatment or could be on treatment with other drugs but have not responded adequately to treatment

You may not qualify if:

  • Patients with known hypersensitivity to Tamsulosin, or any other component of the product
  • Patients with a history of orthostatic hypotension or severe liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

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, 2004

Primary Completion

November 1, 2004

Last Updated

September 19, 2014

Record last verified: 2014-09