Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia

Sanofi

Status and phase

Completed

Phase 2

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: SL77.0499-10 (alfuzosin hydrochloride)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00409357

DRI5234

Details and patient eligibility

About

The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.

Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.

Enrollment

473 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

suffering from LUTS related to BPH for at least 6 months;
having an IPSS >13;
having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
having a residual urine volume < or = 200 mL.