Status:
COMPLETED
Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Gangnam Severance Hospital
Conditions:
Endocrine System Diseases
Nutritional and Metabolic Diseases
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 Stati...
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 compa...
Eligibility Criteria
Inclusion
- Screening (Visit 1) Inclusion Criteria
- Korean men and women aged 40 to 75
- Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
- Who have the following laboratory values on an empty stomach
- Patients with no prior statin therapy
- Low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
- 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
- Patients currently receiving low- or moderate-intensity statin therapy
- • Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
- 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
- Those with less than 9% HbA1C
- Those who voluntarily agreed to participate in this clinical trial and signed a written ICF
- Randomization (Visit 2) Inclusion Criteria
- 1\) Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment
Exclusion
- Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
- Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
- Patients with Body Mass Index (BMI) \< 15 kg/ m2 or \> 35 kg/m2
- Persons with the following medical history or surgical/interventional history
- Atherosclerotic disease occurring within 24 weeks at screening
- Myopathy including rhabdomyolysis
- Patients who have had a history of drug or alcohol abuse, or who have met drug or alcohol abuse criteria within 1 year at screening
- Major mental illness (depression, bipolar disorder, etc.)
- Malignant tumor within 5 years at screening
- Persons with the following comorbidities and laboratory abnormalities
- CK ≥ 2 X ULN
- Patients with severe hepatopathy (AST or ALT \> 5 X ULN)
- Patients with unexplained persistent ALT elevation opinion or active liver disease
- TSH (Thyroid stimulating hormone) \> 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator's judgment
- Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
- Renal disorder patients with severe renal failure (creatinine clearance (CLcr)\<30 mL/min
- Those who have the following history of drug administration within 3 months at screening
- Non-statin lipid modulators
- Foods or drugs that affect lipid control
- Systemic steroids
- Those who are expected to administer contraindication drugs during clinical trial, including screening
- Those who have persistent history of drinking within 1 week at clinical trial participation or who are unable to perform TLC due to continuous drinking during clinical trial
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
- Those who received other IPs or investigational medical devices within 30 days at screening
- Patients judged to be ineligible to participate in clinical trial by investigator's decision
Key Trial Info
Start Date :
January 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04700436
Start Date
January 3 2020
End Date
February 13 2024
Last Update
August 14 2025
Active Locations (26)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
3
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
4
Keimyung University Dongsan Medical Center
Daegu, South Korea