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

Kissei

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Drug: KSO-0400; Drug: Silodosin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222650

KSO1201

Details and patient eligibility

About

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.

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 4 patient groups, including a placebo group

KSO-0400 Low Dose

Experimental group

Treatment:

Drug: KSO-0400

Drug: KSO-0400

KSO-0400 High Dose

Experimental group

Treatment:

Drug: KSO-0400

Drug: KSO-0400

Silodosin

Experimental group

Treatment:

Drug: Silodosin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo