Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

afuzosin

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasiam, Adrenergic alpha-antagonist

Eligibility Criteria

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

Inclusion Criteria: Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography Suffering for at least 6 months from lower urinary tract symptoms related to BPH An I-PSS total score ≥ 13 Out patient Exclusion Criteria: Patients previously treated with SL77.0499-10. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology. Isolated bladder neck disease. Diagnosed carcinoma of the prostate. Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH. Patients having an indwelling catheter. A residual urine > 200mL. Patients with Moderate or sever hepatic insufficiency. Known hypersensitivity to alpha1-blockers. Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

One year safety data of SL77.0499-10

Secondary Outcome Measures

One year efficacy data and plasma concentration of SL77.0499-10

Full Information

NCT ID

NCT00347061

First Posted

June 30, 2006

Last Updated

October 1, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00347061

Brief Title

Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

Official Title

A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

Primary: To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH. Secondary: To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH. To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.

6. Conditions and Keywords

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

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasiam, Adrenergic alpha-antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

afuzosin

Primary Outcome Measure Information:

Title

One year safety data of SL77.0499-10

Secondary Outcome Measure Information:

Title

One year efficacy data and plasma concentration of SL77.0499-10

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography Suffering for at least 6 months from lower urinary tract symptoms related to BPH An I-PSS total score ≥ 13 Out patient Exclusion Criteria: Patients previously treated with SL77.0499-10. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology. Isolated bladder neck disease. Diagnosed carcinoma of the prostate. Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH. Patients having an indwelling catheter. A residual urine > 200mL. Patients with Moderate or sever hepatic insufficiency. Known hypersensitivity to alpha1-blockers. Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Tokyo

Country

Japan

Benign Prostatic Hyperplasia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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