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Completed

NCT Number: NCT01222650

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Japan

Kanto Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KSO-0400

Drug

Silodosin

Drug

Placebo

Drug

Primary outcomes

  1. Change in I-PSS Total Score from baseline

    Time frame: Baseline and 12 weeks (LOCF)

Secondary outcomes

  1. Change in I-PSS Sub-score from baseline

    Time frame: Baseline and 12 weeks (LOCF)

  2. Change in QOL Score from baseline

    Time frame: Baseline and 12 weeks (LOCF)

  3. Change in Qmax (maximum urinary flow rate) from baseline

    Time frame: Baseline and 12 weeks (LOCF)

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

First posted
Oct 18, 2010
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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