Hyperlipidemia (E.G., Hypercholesterolemia)
Conditions
Keywords
increased LDL-C level, Hyperlipidemia, Atorvastatin (10 mg) and Ezetimibe (10 mg)
Brief 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
Interventions
DRUGAtorvastatin 10 mg and ezetimibe 10 mg
Atorvastatin/Ezetimibe 10/10mg once daily
Atorvastatin (20 mg) Monotherapy once daily
Sponsors
Dr. Md. Alimur Reza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in LDL-C from baseline | Baseline to Week 12 | Compare the mean change in LDL-C (mg/dL) from baseline to week 12 in both groups. |
| Percentage of patients withdrawn from the study | Baseline to Week 12 | Compare the percentage of patients withdrawn from the study due to adverse events in two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of myopathy | Baseline to Week 12 | Compare the frequency of myopathy after 12 weeks between two arms |
| Frequency of AEs & SAEs | Baseline to Week 12 | Compare the frequency of AEs & SAEs between two arms |
| Achievement of target levels of LDL-C | Baseline to Week 12 | Compare the frequency of achieving the target levels of LDL-C in both groups after 12 weeks |
| Changes in Serum Creatinine Levels in Both Arms | Baseline to Week 12 | Compare the changes in SGPT (U/L) levels in both arms. |
| Changes in creatine phosphokinase (CPK) level in Both Arms | Baseline to Week 12 | Compare the changes in creatine phosphokinase (CPK) level in Both Arms |
| Changes in SGPT Levels in Both Arms | Baseline to Week 12 | Compare the change in SGPT (U/L) levels in both arms. |
| Mean changes in total cholesterol (TC), HDL-C and TG | Baseline to Week 12 | Compare the mean changes in total cholesterol (TC), HDL-C and TG from baseline to week 12 in both arms. |
Countries
Bangladesh
Contacts
Primary ContactDr. Md. Alimur Reza, MBBS, MPH
Outcome results
None listed