MedTrace Logo

Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia

NCT04700436 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-08-14

No results posted yet for this study

Summary

To compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG \> 200 mg/dL).

Conditions

  • Endocrine System Diseases
  • Nutritional and Metabolic Diseases
  • Diabetes Mellitus, Type 2
  • Dyslipidemias

Interventions

DRUG

Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

DRUG

Suvast tablet 10 mg (Rosuvastatin 10 mg)

\- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)

Sponsors & Collaborators

  • Gangnam Severance Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Kyong Soo Park, Dr. · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2021-05-28
Completion
2024-02-13

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT04700436 on ClinicalTrials.gov