NCT06789432

Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Dr. Md. Alimur Reza · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Hyperlipidemia (E.G., Hypercholesterolemia)

Interventions

Type	Name	Description
DRUG	Atorvastatin 10 mg and ezetimibe 10 mg	Atorvastatin/Ezetimibe 10/10mg once daily
DRUG	Atorvastatin 20 mg	Atorvastatin (20 mg) Monotherapy once daily

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-01-23
• Last updated: 2025-07-29

Locations

1 site across 1 country: Bangladesh