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

NCT04882228 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2021-05-11

No results posted yet for this study

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.

Conditions

  • Chronic Venous Disease

Interventions

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.)

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2022-02-28
Completion
2022-02-28

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 NCT04882228 on ClinicalTrials.gov