Actively Recruiting
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
Led by Dr. Md. Alimur Reza · Updated on 2025-07-29
500
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population. Researchers will compare atorvastatin (10 mg) and ezetimibe (10 mg) to atorvastatin (20 mg) monotherapy to see if atorvastatin (10 mg) and ezetimibe (10 mg) FDC works to treat dyslipidemia. Participants will: * Take a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy for 3 months * Follow-up visits at 6 weeks and 12 weeks for checkups and tests
CONDITIONS
Official Title
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged over 18 years
- Confirmed diagnosis of elevated LDL-C levels requiring medical management
- Low to moderate cardiovascular disease risk according to ESC guidelines (2019)
- Low-risk: Increased LDL-C without other co-morbidities
- Moderate-risk: Young patients with type 1 diabetes under 35 years or type 2 diabetes under 50 years with diabetes duration less than 10 years and no other risk factors
You will not qualify if you...
- History of hypersensitivity to any study drugs
- Significant liver impairment (ALT, AST levels more than twice upper limit of normal)
- Significant kidney impairment (serum creatinine levels at least twice upper limit of normal)
- Presence of hepatitis B or C with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV positive status, or intestinal malabsorption
- Pregnant or breastfeeding females
- Any condition that investigator believes increases risk from study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Popular Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh
Actively Recruiting
Research Team
D
Dr. Md. Alimur Reza, MBBS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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