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Once Daily Given Alfuzosin in the Treatment of BPH

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

Alfuzosin

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria:

Necessity of surgical intervention immediately or within 12 months because of BPH
The patient has earlier /within 6 months/ obtained treatment because of BPH
The patient did not improve on earlier alpha-1 blocker treatment
Known hypersensitivity to alfuzosin
Orthostatic hypotension in the history
Concomitant application with another alpha-1 blocker
Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
Intestinal obstruction /because of the castor oil content of the drug/
Tumorous disease
Severe, life threatening state

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)

Secondary Outcome Measures

Full Information

NCT ID

NCT00637715

First Posted

March 11, 2008

Last Updated

April 1, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00637715

Brief Title

Once Daily Given Alfuzosin in the Treatment of BPH

Official Title

Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alfuzosin

Primary Outcome Measure Information:

Title

To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present Exclusion Criteria: Necessity of surgical intervention immediately or within 12 months because of BPH The patient has earlier /within 6 months/ obtained treatment because of BPH The patient did not improve on earlier alpha-1 blocker treatment Known hypersensitivity to alfuzosin Orthostatic hypotension in the history Concomitant application with another alpha-1 blocker Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/ Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/ Intestinal obstruction /because of the castor oil content of the drug/ Tumorous disease Severe, life threatening state The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laszlo Eros

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Budapest

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

Once Daily Given Alfuzosin in the Treatment of BPH

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