A Comparative Study of KSO-0400 in BPH Patients With LUTS

A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222650

Enrollment

400

Registered

2010-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2011-07-04

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist

Brief summary

The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.

Interventions

DRUGKSO-0400

DRUGSilodosin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* BPH patients with LUTS

Exclusion criteria

* Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia * Patients with prostate cancer or suspected prostate cancer * Patients who have any clinically relevant cardiovascular, hepatic or renal disorder

Design outcomes

Primary

Measure	Time frame
Change in I-PSS Total Score from baseline	Baseline and 12 weeks (LOCF)

Secondary

Measure	Time frame
Change in I-PSS Sub-score from baseline	Baseline and 12 weeks (LOCF)
Change in QOL Score from baseline	Baseline and 12 weeks (LOCF)
Change in Qmax (maximum urinary flow rate) from baseline	Baseline and 12 weeks (LOCF)

Countries

Japan

Outcome results

None listed

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