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NCT Number: NCT06789432

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

Recruiting

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Key information

Conditions

Hyperlipidemia (E.G., Hypercholesterolemia) Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin 10 mg and ezetimibe 10 mg

Drug

Atorvastatin/Ezetimibe 10/10mg once daily

Atorvastatin 20 mg

Drug

Atorvastatin (20 mg) Monotherapy once daily

Primary outcomes

  1. Mean change in LDL-C from baseline

    Time frame: Baseline to Week 12

    Compare the mean change in LDL-C (mg/dL) from baseline to week 12 in both groups.

  2. Percentage of patients withdrawn from the study

    Time frame: Baseline to Week 12

    Compare the percentage of patients withdrawn from the study due to adverse events in two groups.

Secondary outcomes

  1. Achievement of target levels of LDL-C

    Time frame: Baseline to Week 12

    Compare the frequency of achieving the target levels of LDL-C in both groups after 12 weeks

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

    Time frame: Baseline to Week 12

    Compare the mean changes in total cholesterol (TC), HDL-C and TG from baseline to week 12 in both arms.

  3. Frequency of myopathy

    Time frame: Baseline to Week 12

    Compare the frequency of myopathy after 12 weeks between two arms

  4. Frequency of AEs & SAEs

    Time frame: Baseline to Week 12

    Compare the frequency of AEs & SAEs between two arms

  5. Changes in SGPT Levels in Both Arms

    Time frame: Baseline to Week 12

    Compare the change in SGPT (U/L) levels in both arms.

  6. Changes in Serum Creatinine Levels in Both Arms

    Time frame: Baseline to Week 12

    Compare the changes in SGPT (U/L) levels in both arms.

  7. Changes in creatine phosphokinase (CPK) level in Both Arms

    Time frame: Baseline to Week 12

    Compare the changes in creatine phosphokinase (CPK) level in Both Arms

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Md. Alimur Reza, MBBS, MPH

CONTACT

[email protected]

+8801711438139

Sponsors and collaborators

Lead sponsor

Dr. Md. Alimur Reza

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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