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Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

NCT04947631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2023-09-21

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients with benign prostatic hyperplasia.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

DKF-313

Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks

DRUG

Dutasteride

Dutasteride 0.5 mg once daily for 48 weeks

DRUG

Tadalafil

Tadalafil 5 mg once daily for 48 weeks

DRUG

DKF-313 placebo

Once daily for 48 weeks

DRUG

Dutasteride placebo

Once daily for 48 weeks

DRUG

Tadalafil placebo

Once daily for 48 weeks

Sponsors & Collaborators

  • Dongkook Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Choung-Soo Kim, M.D.,Ph.D · Ewha Womans University Mokdong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-06-12
Completion
2023-06-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947631 on ClinicalTrials.gov