NCT04882228

Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)

A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group, Non-inferiority Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a multi-center, double-blind, randomized, active controlled , parallel design, non-inferiority phase 4 study to evaluate the efficacy and safety of Entelon 150mg in 278 patients with chronic venous disease.

Detailed description

This study is to prove that Entelon tab. 150mg is non-inferior in clinical efficacy and safety compared to Venitol tab. for 8 weeks in patients suffering from chronic venous disease.

Conditions

• Chronic Venous Disease

Interventions

Type	Name	Description
DRUG	Entelon Tab.150mg	twice daily for 8 weeks
DRUG	Venitol Tab.	twice daily for 8 weeks
DRUG	Placebo of Venitol Tab.	twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
DRUG	Placebo of Entelon Tab.150mg	twice daily for 8 weeks(with Venitol Tab. It is for the masking.)

Timeline

• Start date: 2021-01-28
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-05-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: South Korea