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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10 mg and ezetimibe 10 mg | Drug | Atorvastatin/Ezetimibe 10/10mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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| Percentage of patients withdrawn from the study | Compare the percentage of patients withdrawn from the study due to adverse events in two groups.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 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of target levels of LDL-C | Compare the frequency of achieving the target levels of LDL-C in both groups after 12 weeks | Baseline to Week 12 |
| Mean changes in total cholesterol (TC), HDL-C and TG |
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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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Md. Alimur Reza, MBBS, MPH | Contact | +8801711438139 | rea@bpl.net |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G) | Professor, Dept. of Cardiology, Popular Medical College, Dhaka. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Popular Medical College & Hospital | Recruiting | Dhaka | Dhaka Division | Bangladesh |
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This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.
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| Atorvastatin 20 mg |
| Drug |
Atorvastatin (20 mg) Monotherapy once daily |
|
Compare the mean changes in total cholesterol (TC), HDL-C and TG from baseline to week 12 in both arms.
| Baseline to Week 12 |
| Frequency of myopathy | Compare the frequency of myopathy after 12 weeks between two arms | Baseline to Week 12 |
| Frequency of AEs & SAEs | Compare the frequency of AEs & SAEs between two arms | Baseline to Week 12 |
| Changes in SGPT Levels in Both Arms | Compare the change in SGPT (U/L) levels in both arms. | Baseline to Week 12 |
| Changes in Serum Creatinine Levels in Both Arms | Compare the changes in SGPT (U/L) levels in both arms. | Baseline to Week 12 |
| Changes in creatine phosphokinase (CPK) level in Both Arms | Compare the changes in creatine phosphokinase (CPK) level in Both Arms | Baseline to Week 12 |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |
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