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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia (E.G., Hypercholesterolemia)
• Intervention / Treatment: Drug: Atorvastatin 10 mg and ezetimibe 10 mg; Drug: Atorvastatin 20 mg

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Md. Alimur Reza, MBBS, MPH; Phone Number: +8801711438139; Email: rea@bpl.net

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Recruiting
    • Popular Medical College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women aged >18 years.
• Patients with a confirmed diagnosis of elevated LDL-C levels necessitating medical management.

• Patients in the low to moderate cardiovascular disease (CVD) risk category according to ESC guidelines (2019)

  • Low-risk: Increased LDL-C level without any co-morbidities
  • Moderate-risk: Young patients (T1DM <35 years; T2DM <50 years) with DM duration <10 years, without other risk factors.

Exclusion Criteria:

• History of hypersensitivity to any study drugs.
• Clinically significant hepatic impairment (ALT, AST level > 2xULN) and/or renal impairment (Serum creatinine level ≥2xULN).
• Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.
• Pregnant or lactating females.
• The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Atorvastatin 10 mg and ezetimibe 10 mg; Atorvastatin/Ezetimibe 10/10mg once daily
Experimental: Arm 2	Drug: Atorvastatin 20 mg; Atorvastatin (20 mg) Monotherapy once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients withdrawn from the study	Compare the percentage of patients withdrawn from the study due to adverse events in two groups.	Baseline to Week 12
Mean change in LDL-C from baseline	Compare the mean change in LDL-C (mg/dL) from baseline to week 12 in both groups.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of target levels of LDL-C	Compare the frequency of achieving the target levels of LDL-C in both groups after 12 weeks	Baseline to Week 12
Mean changes in total cholesterol (TC), HDL-C and TG	Compare the mean changes in total cholesterol (TC), HDL-C and TG from baseline to week 12 in both arms.	Baseline to Week 12
Frequency of myopathy	Compare the frequency of myopathy after 12 weeks between two arms	Baseline to Week 12
Frequency of AEs & SAEs	Compare the frequency of AEs & SAEs between two arms	Baseline to Week 12
Changes in SGPT Levels in Both Arms	Compare the change in SGPT (U/L) levels in both arms.	Baseline to Week 12
Changes in Serum Creatinine Levels in Both Arms	Compare the changes in SGPT (U/L) levels in both arms.	Baseline to Week 12
Changes in creatine phosphokinase (CPK) level in Both Arms	Compare the changes in creatine phosphokinase (CPK) level in Both Arms	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Dr. Md. Alimur Reza
• Investigators: Principal Investigator: Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G), Professor, Dept. of Cardiology, Popular Medical College, Dhaka.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hyperlipidemia; increased LDL-C level; Atorvastatin (10 mg) and Ezetimibe (10 mg)
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: BEX2411001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No