Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Bangladesh
Popular Medical College & Hospital
RECRUITING
Dhaka
Contact Information
Primary
Dr. Md. Alimur Reza, MBBS, MPH
rea@bpl.net
+8801711438139
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 500
Treatments
Experimental: Arm 1
Experimental: Arm 2
Related Therapeutic Areas
Sponsors
Leads: Dr. Md. Alimur Reza

This content was sourced from clinicaltrials.gov