drugset / Trial / NCT06789432

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

NCT06789432 ↗

Phase 4 Withdrawn Dr. Md. Alimur Reza
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2025-02-01
Primary completion
2025-10
Completion
2025-12

Outcome

Outcome not reported

Stopped (Enrollment): “Withdrawn by the sponsor before any participant was enrolled. Protocol-specified screening and randomization were not initiated at the study site. Not related to participant safety.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg —
Subject Atorvastatin Small molecule 20 mg —
Subject Ezetimibe Unknown 10 mg —

Indications