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

Beximco

Status and phase: Enrolling; Phase 4

Conditions: Hyperlipidemia (E.G., Hypercholesterolemia)

Treatments: Drug: Atorvastatin 20 mg; Drug: Atorvastatin 10 mg and ezetimibe 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06789432

BEX2411001

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Atorvastatin 10 mg and ezetimibe 10 mg

Arm 2

Experimental group

Treatment:

Drug: Atorvastatin 20 mg