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

A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00347061

Enrollment

148

Registered

2006-07-04

Start date

2006-05-31

Completion date

2007-10-31

Last updated

2009-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasiam, Adrenergic alpha-antagonist

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.

Interventions

DRUGafuzosin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
One year safety data of SL77.0499-10	—

Secondary

Measure	Time frame
One year efficacy data and plasma concentration of SL77.0499-10	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026