NCT04700436

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

A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetimiBe/Rosuvastatin Diabetic Dislipidemia With Hypertriglyceridaemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is 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

Type	Name	Description
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)

Timeline

• Start date: 2020-01-03
• Primary completion: 2021-05-28
• Completion: 2024-02-13
• First posted: 2021-01-07
• Last updated: 2025-08-14

Locations

26 sites across 1 country: South Korea