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A study to compare the effectiveness and safety of bempedoic acid and ezetimibe for treating high lipid levels

A Comparative study to evaluate the efficacy and safety of Bempedoic acid versus Ezetimibe in patients with Dyslipidemia - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070838
Enrollment
106
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: Bempedoic acid: Dose: 180 mg Frequency: OD (once a day) Route: Oral Duration: 12 weeks Control Intervention1: Ezetimibe: Dose: 10 mg Frequency: OD (once a day) Route: Oral Duration: 1

Sponsors

Afzal Noor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Stable atherosclerotic cardiovascular disease Uncontrolled LDL cholesterol level (fasting more than 70 mg/dl) on maximally tolerated dose of statin.(Atrovastatin 80 mg OD, Rosuvastatin 40 mg OD)

Exclusion criteria

Exclusion criteria: Age less than 18 yr BMI more or equal 40 kg/m sq. Triglyceride levels more or equal to 500 mg/dl History of statin intolerance History of cardiac event in last 12 weeks Pregnant and Lactating women.

Design outcomes

Primary

MeasureTime frame
Achieving the target level of fasting LDL-C less than 70 mg/dlTimepoint: 0 week 6 weeks 12 weeks

Secondary

MeasureTime frame
The study shall further examine the adverse drug reaction caused by Bempedoic acid 180 mg and Ezetimibe 10 mg in patients of dyslipidemia.Timepoint: 0,6,12th weeks

Countries

India

Contacts

Public ContactAfzal Noor

Eras Lucknow Medical College

dr.dilshadali@yahoo.com9450025751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026