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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: afuzosin

Study type

Interventional

Funder types

Industry

Identifiers

LTS5235

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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.