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

H

Hanlim Pharm

Status and phase

Unknown
Phase 4

Conditions

Chronic Venous Disease

Treatments

Drug: Placebo of Entelon Tab.150mg
Drug: Entelon Tab.150mg
Drug: Placebo of Venitol Tab.
Drug: Venitol Tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT04882228
HL_ENTL_401

Details and patient eligibility

About

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.

Full 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.

Enrollment

278 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 19 years ≤ age ≤ 80 years

  2. Those who are diagnosed as CEAP Classification Class 1 ~ Class 3

  3. Those who have the Venous Duplex ultrasonography result at least one of the following

    • reflux more than 1 second in Femoral vein or Popliteal vein
    • reflux more that 0.5 second in GSV or SSV or Accessory saphenous vein or perforating vein or calf vein
  4. Those who have completed the washout period as following until the baseline, including the screening period

    • Analgesic, corticosteroids, anti-inflammatory drugs: at least 2 weeks
  5. Those who provide written consent voluntarily to participate in this clinical trial

Exclusion criteria

  1. Those who must wear compression stockings
  2. Those who have obstruction of the peripheral arteries of the lower extremities
  3. Those who have asymptomatic varicose veins
  4. Those who have acute deep vein thrombosis
  5. Those who have frequent lower extremity pain due to neuropathy
  6. Varicose vein surgery patient or prospective person (if surgery was done more than 1 year prior to the time of screening, recruitment is possible)
  7. Those who have systemic disease that causes edema or thrombosis
  8. Those who have a history of malignant tumors within 5 years prior to the time of screening
  9. Those who have severe renal dysfunction at the time of screening (serum creatinine ≥ 2 x upper limit of normal)
  10. Those who have severe liver dysfunction at the time of screening (AST or ALT ≥ 3 x upper limit of normal)
  11. Those who are required to receive diuretics, analgesics, corticosteroids, anti-inflammatory drugs, or contraindications that may affect the outcome of this clinical trial during the clinical trial period
  12. Those who have a history of significant mental illness, alcohol abuse
  13. Patients who have an allergy to investigational product or any of its excipients
  14. Patients who participated in other clinical trials within 12 weeks prior to the date of screening
  15. Pregnant or lactating woman
  16. Those who do not agree to use an effective method of contraception
  17. Individual considered by the investigator to be ineligible for study participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

278 participants in 2 patient groups

Entelon Tab.150mg
Experimental group
Treatment:
Drug: Placebo of Venitol Tab.
Drug: Entelon Tab.150mg
Venitol tab.
Active Comparator group
Treatment:
Drug: Venitol Tab.
Drug: Placebo of Entelon Tab.150mg

Trial contacts and locations

1

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Central trial contact

Nahyun Kang

Data sourced from clinicaltrials.gov

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