Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-03-31

Brief Summary

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To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Detailed Description

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Conditions

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Prostatic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Alfuzosin

Alfuzosin 10 mg One tablet per day after evening meal

Intervention Type DRUG

Other Intervention Names

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(Xatral XL)

Eligibility Criteria

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Inclusion Criteria

* Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion Criteria

* Patients requiring BPH surgery immediately or within the 12 following months:

* Acute renal obstruction
* Chronic renal obstruction
* Chronic renal failure from BPH
* Bladder stone
* Recurrent urinary tract infection
* Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
* Hematuria from BPH
* Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
* Patients previously not improved by an alpha1-blocker treatment
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Combination with other alpha1-blockers
* Hepatic enzyme (SGOT or/and SGPT ) \> 1.5 Upper Normal Limit
* Unstable angina pectoris
* Severe concomitant condition threatening life.
* Patients who had failed treatment with finasteride (Proscar)
* Patients with neuropathic bladder.
* Patients with history of previous surgery for BPH
* Patients with high risk for prostate cancer based on the clinical judgement of the investigator

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Paibulsirijit Sompob

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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L_8935

Identifier Type: -

Identifier Source: org_study_id