ALF-ONE : ALFuzosin ONcE Daily

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alfuzosin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benedict Blayney, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PM_L_0168

Identifier Type: -

Identifier Source: org_study_id