Clinical trial NCT06789432: Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
Official title: Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hyperlipidemia (E.G., Hypercholesterolemia)
Keywords: increased LDL-C level
Hyperlipidemia
Atorvastatin (10 mg) and Ezetimibe (10 mg)
Lead sponsor: Beximco Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in LDL-C from baseline
timeFrame: Baseline to Week 12
measure: Percentage of patients withdrawn from the study
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Achievement of target levels of LDL-C
timeFrame: Baseline to Week 12
measure: Mean changes in total cholesterol (TC), HDL-C and TG
timeFrame: Baseline to Week 12
measure: Frequency of myopathy
timeFrame: Baseline to Week 12
measure: Frequency of AEs & SAEs
timeFrame: Baseline to Week 12
measure: Changes in SGPT Levels in Both Arms
timeFrame: Baseline to Week 12
measure: Changes in Serum Creatinine Levels in Both Arms
timeFrame: Baseline to Week 12
measure: Changes in creatine phosphokinase (CPK) level in Both Arms
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Popular Medical College & Hospital
Study officials:
affiliation: Professor, Dept. of Cardiology, Popular Medical College, Dhaka.
name: Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G)
role: PRINCIPAL_INVESTIGATOR
References: