Prescription Event Monitoring in Patients With Benign Pro... | NCT02244346

Studies
Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

NCT02244346

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 19, 2014Estimated

Enrollment

811Actual

Phase

Not provided

Conditions

Prostatic Hyperplasia

Interventions

Secotex®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Nov 2004Actual

Completion Date

Not provided

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

811Actual

Label	Type	Description	Intervention Names
Benign prostatic hyperplasia patients			Drug: Secotex®

Name	Type	Description	Arm Group Labels	Other Names
Secotex®	Drug		Benign prostatic hyperplasia patients

Measure	Description	Time Frame
Number of patients with adverse events		up to 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated with Secotex® in the daily clinical practice

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided