NCT06789432WithdrawnPhase 4
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Reason given: Withdrawn by the sponsor before any participant was enrolled. Protocol-specified screening and randomization were not initiated at the study site. Not related to participant safety.
Brief summary (registry, in English)
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
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 17 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- Oct 2025
- Lead sponsor
- Dr. Md. Alimur Reza
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06789432
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of hypersensitivity to any study drugs.
- Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.
- The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.
Lab values
- Clinically significant hepatic impairment (ALT, AST level > 2xULN) and/or renal impairment (Serum creatinine level ≥2xULN).
Other
- Pregnant or lactating females.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Popular Medical College & Hospital | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.