ALF-ONE : ALFuzosin ONcE Daily | NCT00280605

Studies
ALF-ONE : ALFuzosin ONcE Daily

NCT00280605

Sponsor

Sanofi

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

200

Phase

Phase 4

Conditions

Prostatic Hyperplasia

Interventions

Alfuzosin

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

Aug 2010

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

Aug 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jan 20, 2006

First Submission Date that Met QC Criteria

Jan 20, 2006

First Posted Date

Jan 23, 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

Aug 30, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Description Module

Brief Summary

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spontaneous adverse events
Blood pressure and heart rate measured in sitting position
International Prostate Symptom Score (IPSS) and quality of life index
DAN-PSS sexual function score
PSA levels measured at baseline
Maximum flow rate and residual urine

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion Criteria:

Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
Patients previously not improved by an alpha 1-blocker treatment
Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Combination with other alpha 1-blockers
Hepatic insufficiency
Unstable angina pectoris
Severe concomitant condition threatening life

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Benedict Blayney, MD	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

Intervention Browse Module

MeSH Terms

ID	Term
C047638	alfuzosin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided