Once Daily Given Alfuzosin in the Treatment of BPH

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-12-31

Brief Summary

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Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria

* Necessity of surgical intervention immediately or within 12 months because of BPH
* The patient has earlier /within 6 months/ obtained treatment because of BPH
* The patient did not improve on earlier alpha-1 blocker treatment
* Known hypersensitivity to alfuzosin
* Orthostatic hypotension in the history
* Concomitant application with another alpha-1 blocker
* Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
* Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
* Intestinal obstruction /because of the castor oil content of the drug/
* Tumorous disease
* Severe, life threatening state

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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Laszlo Eros

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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L_8758

Identifier Type: -

Identifier Source: org_study_id