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

Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399464

Enrollment

1177

Registered

2006-11-14

Start date

2006-11-30

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

Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia, Adrenergic alpha-Antagonists, alfuzosin

Brief summary

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.

Interventions

DRUGalfuzosin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)	—

Secondary

Measure	Time frame
Efficacy: Change in I-PSS total score from baseline to each visit	—
Change in Quality Of Life score from baseline to each visit	—
Change from baseline to endpoint of residual urine volume and urinary Peak Flow	—
Safety:Adverse events	—

Countries

Japan

Outcome results

None listed

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