Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients... | NCT00347061

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

NCT00347061

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 2, 2009Estimated

Enrollment

148Actual

Phase

Phase 3

Conditions

Benign Prostatic Hyperplasia

Interventions

afuzosin

Countries

Japan

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

Oct 2009

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 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

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

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Name	Type	Description	Arm Group Labels	Other Names
afuzosin	Drug

Measure	Description	Time Frame
One year safety data of SL77.0499-10

Measure	Description	Time Frame
One year efficacy data and plasma concentration of SL77.0499-10

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

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