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RecruitingPhase 4NCT06789432

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

Sponsor

Dr. Md. Alimur Reza

Enrollment

500 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperlipidemia (E.G., Hypercholesterolemia)

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

DRUGAtorvastatin 10 mg and ezetimibe 10 mg

Atorvastatin/Ezetimibe 10/10mg once daily

DRUGAtorvastatin 20 mg

Atorvastatin (20 mg) Monotherapy once daily

Locations(1)

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

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NCT06789432