NCT04947631

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

A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Dongkook Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as measured by changes in IPSS total scores.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2021-07-01
• Last updated: 2023-09-21

Locations

1 site across 1 country: South Korea