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

ConditionHyperlipidemia (E.G., Hypercholesterolemia)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Md. Alimur Reza

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 10 mg and ezetimibe 10 mg

    Drug

    Atorvastatin/Ezetimibe 10/10mg once daily

  • Atorvastatin 20 mg

    Drug

    Atorvastatin (20 mg) Monotherapy once daily

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in LDL-C from baseline

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

Time frame
Baseline to Week 12
2

Percentage of patients withdrawn from the study

Compare the percentage of patients withdrawn from the study due to adverse events in two groups.

Time frame
Baseline to Week 12

Secondary outcomes

1

Achievement of target levels of LDL-C

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

Time frame
Baseline to Week 12
2

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.

Time frame
Baseline to Week 12
3

Frequency of myopathy

Compare the frequency of myopathy after 12 weeks between two arms

Time frame
Baseline to Week 12
4

Frequency of AEs & SAEs

Compare the frequency of AEs \& SAEs between two arms

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Md. Alimur Reza

Lead sponsor

Beximco Pharmaceuticals Ltd.

Sponsor institution

Source ClinicalTrials.gov
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