Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
NCT ID: NCT06789432
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2025-02-01
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Atorvastatin 10 mg and ezetimibe 10 mg
Atorvastatin/Ezetimibe 10/10mg once daily
Arm 2
Atorvastatin 20 mg
Atorvastatin (20 mg) Monotherapy once daily
Interventions
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Atorvastatin 10 mg and ezetimibe 10 mg
Atorvastatin/Ezetimibe 10/10mg once daily
Atorvastatin 20 mg
Atorvastatin (20 mg) Monotherapy once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Dr. Md. Alimur Reza
INDUSTRY
Responsible Party
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Dr. Md. Alimur Reza
Epidemiologist
Principal Investigators
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Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G)
Role: PRINCIPAL_INVESTIGATOR
Professor, Dept. of Cardiology, Popular Medical College, Dhaka.
Locations
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Popular Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh
Countries
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Central Contacts
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Other Identifiers
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BEX2411001
Identifier Type: -
Identifier Source: org_study_id
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