Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

Sanofi

Status and phase

Completed

Phase 3

Conditions

Prostatic Hyperplasia

Treatments

Drug: alfuzosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00399464

EFC5791

Details and patient eligibility

About

The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.

Enrollment

1,177 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Japanese;
Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion criteria

Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
Inpatient;
Patients having participated in a clinical trial within the previous 6-month;
Patients previously treated with SL77.0499-10;
Patients whose I-PSS total score do not meet ≥ 13;
Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
Patients whose residual urine are > 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.