clinical trial · NCT04947631
Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
Dongkook Pharmaceutical Co., Ltd.·phase3·completed·n = 667
Benign Prostatic HyperplasiaDKF-313DutasterideTadalafilDKF-313 placeboDutasteride placeboTadalafil placebo
brief 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.
started
Jul 27, 2021
primary completion
Jun 12, 2023
completion
Jun 12, 2023
last updated
Sep 21, 2023
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol