Hyperlipidemia (E.G., Hypercholesterolemia)Phase 4NCT06789432
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
A Phase 4 study testing Atorvastatin 10 mg and ezetimibe 10 mg and Atorvastatin 20 mg in people with Hyperlipidemia (E.G., Hypercholesterolemia), run by Dr. Md. Alimur Reza at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia (E.G., Hypercholesterolemia)
- What is being tested?
- Atorvastatin 10 mg and ezetimibe 10 mg and Atorvastatin 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Atorvastatin 10 mg and ezetimibe 10 mg, Atorvastatin 20 mg
- Keywords
- increased LDL-C level, Hyperlipidemia, Atorvastatin (10 mg) and Ezetimibe (10 mg)
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10 mg and ezetimibe 10 mgDrug
Atorvastatin/Ezetimibe 10/10mg once daily
Atorvastatin 20 mgDrug
Atorvastatin (20 mg) Monotherapy once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Atorvastatin 10 mg and ezetimibe 10 mg |
| Arm 2 | Experimental | Not described Receives: Drug: Atorvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in LDL-C from baseline
Compare the mean change in LDL-C (mg/dL) from baseline to week 12 in both groups.
Measured: Baseline to Week 12
Percentage of patients withdrawn from the study
Compare the percentage of patients withdrawn from the study due to adverse events in two groups.
Measured: Baseline to Week 12
Secondary outcomes (7)
Achievement of target levels of LDL-C
Compare the frequency of achieving the target levels of LDL-C in both groups after 12 weeks
Measured: Baseline to Week 12
Mean changes in total cholesterol (TC), HDL-C and TG
Compare the mean changes in total cholesterol (TC), HDL-C and TG from baseline to week 12 in both arms.
Measured: Baseline to Week 12
Frequency of myopathy
Compare the frequency of myopathy after 12 weeks between two arms
Measured: Baseline to Week 12
Frequency of AEs & SAEs
Compare the frequency of AEs \& SAEs between two arms
Measured: Baseline to Week 12
Changes in SGPT Levels in Both Arms
Compare the change in SGPT (U/L) levels in both arms.
Measured: Baseline to Week 12
Changes in Serum Creatinine Levels in Both Arms
Compare the changes in SGPT (U/L) levels in both arms.
Measured: Baseline to Week 12
Changes in creatine phosphokinase (CPK) level in Both Arms
Compare the changes in creatine phosphokinase (CPK) level in Both Arms
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipidemia (E.G., Hypercholesterolemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Md. Alimur Reza
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Md. Alimur Reza, Beximco Pharmaceuticals Ltd.
- Investigators
- Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G), Principal investigator, Professor, Dept. of Cardiology, Popular Medical College, Dhaka.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789432
- Sponsor's protocol ID
- BEX2411001
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- BEX2411001
- Keywords
- increased LDL-C level, Hyperlipidemia, Atorvastatin (10 mg) and Ezetimibe (10 mg)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Md. Alimur RezaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, multi-centred, open-label, randomized controlled trial in patients with increased LDL-C levels.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Atorvastatin 10 mg and ezetimibe 10 mg |
| Arm 2 | Experimental | Drug: Atorvastatin 20 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 10 mg and ezetimibe 10 mgAtorvastatin/Ezetimibe 10/10mg once daily | Drug | Arm 1 |
| Atorvastatin 20 mgAtorvastatin (20 mg) Monotherapy once daily | Drug | Arm 2 |
Primary outcome
Mean change in LDL-C from baseline
Time frame: 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
Time frame: Baseline to Week 12
Compare the percentage of patients withdrawn from the study due to adverse events in two groups.
7 secondary outcomes
Achievement of target levels of LDL-C
Time frame: Baseline to Week 12
Mean changes in total cholesterol (TC), HDL-C and TG
Time frame: Baseline to Week 12
Frequency of myopathy
Time frame: Baseline to Week 12
Frequency of AEs & SAEs
Time frame: Baseline to Week 12
Changes in SGPT Levels in Both Arms
Time frame: Baseline to Week 12
Changes in Serum Creatinine Levels in Both Arms
Time frame: Baseline to Week 12
Changes in creatine phosphokinase (CPK) level in Both Arms
Time frame: Baseline to Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G) principal investigator
Professor, Dept. of Cardiology, Popular Medical College, Dhaka.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 10 mg and ezetimibe 10 mg and Atorvastatin 20 mg in people with Hyperlipidemia (E.G., Hypercholesterolemia), run by Dr. Md. Alimur Reza at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in LDL-C from baseline (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.