MedTrace Logo

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

NCT06789432 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-07-29

No results posted yet for this study

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

DRUG

Atorvastatin 10 mg and ezetimibe 10 mg

Atorvastatin/Ezetimibe 10/10mg once daily

DRUG

Atorvastatin 20 mg

Atorvastatin (20 mg) Monotherapy once daily

Sponsors & Collaborators

  • Dr. Md. Alimur Reza

    lead INDUSTRY

Principal Investigators

  • Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G) · Professor, Dept. of Cardiology, Popular Medical College, Dhaka.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789432 on ClinicalTrials.gov