RECRUITINGPhase 4INTERVENTIONAL
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Atorvastatin 10 mg and ezetimibe 10 mg
Atorvastatin/Ezetimibe 10/10mg once daily
DRUG
Atorvastatin 20 mg
Atorvastatin (20 mg) Monotherapy once daily
Locations (1)
Popular Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh