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

NCT06789432 | Recruiting Phase 4

• 1 other identifier: BEX2411001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

increased LDL-C level; Hyperlipidemia; Atorvastatin (10 mg) and Ezetimibe (10 mg)

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of patients withdrawn from the study

  Compare the percentage of patients withdrawn from the study due to adverse events in two groups.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

Secondary Outcomes (7)

• Achievement of target levels of LDL-C

  Baseline to Week 12

• Mean changes in total cholesterol (TC), HDL-C and TG

  Baseline to Week 12

• Frequency of myopathy

  Baseline to Week 12

• Frequency of AEs & SAEs

  Baseline to Week 12

• Changes in SGPT Levels in Both Arms

  Baseline to Week 12

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Atorvastatin 10 mg and ezetimibe 10 mg

Arm 2

EXPERIMENTAL

Drug: Atorvastatin 20 mg

Interventions

Atorvastatin 10 mg and ezetimibe 10 mg DRUG

Atorvastatin/Ezetimibe 10/10mg once daily

Arm 1

Atorvastatin 20 mg DRUG

Atorvastatin (20 mg) Monotherapy once daily

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Md. Alimur Reza: lead

Study Sites (1)

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia

Interventions

Atorvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Study Officials

• Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G)

  Professor, Dept. of Cardiology, Popular Medical College, Dhaka.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Md. Alimur Reza, MBBS, MPH

CONTACT

+8801711438139; rea@bpl.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Epidemiologist

Model Details: This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

BA (1)