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Compares treatment options for Hyperlipidemia (E.G., Hypercholesterolemia)
Official title Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
ClinicalTrials.gov ID: NCT06789432
What this study is testing
What is Atorvastatin 10 mg and ezetimibe 10 mg?
Atorvastatin 10 mg and ezetimibe 10 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for hyperlipidemia (e.g., hypercholesterolemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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 +...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Dhaka Division, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Dhaka Division, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.