efficacy, safety and tolerability are checked between two groups of patients already on Atorvastatin 20 but not achieving target LDL-C , where one group receives Atorvastatin 40 and another group receives Atorvastatin 20 and Bempedoic Acid 180mg

Efficacy, safety AND tolerability of add on Bempedoic Acid vs increased dose of Atorvastatin, in patients already on moderate dose of atorvastatin without achieving target LDL-C - A single blind randomised control trial - BA, RCT

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081792

Enrollment

Registered

2025-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Bempedoic acid - 180 mg once daily Bempedoic acid is a non-statin drug which targets the cholesterol biosynthesis pathway in the liver, thus lowering the level of LDL-C.

Eligibility

Inclusion criteria

Inclusion criteria: a. Hypercholesterolemia patients having uncontrolled LDL with moderate dose of Atorvastatin(10-20mg) for at least 3 months, attending Medicine OPD b. Those having the following co-morbidities- stable angina, uncomplicated type 2 Diabetes Mellitus and/or Hypertension

Exclusion criteria

Exclusion criteria: 1.Patients who are not willing to give consent. 2. Who are absolutely intolerant to statin 3. Those having other co-morbidities except stable angina, uncomplicated type 2 Diabetes Mellitus and/or Hypertension. 4. Patients in whom either or both drugs are contraindicated.

Design outcomes

Primary

Measure	Time frame
Proportion of patients reaching the LDL-C targetTimepoint: 24 weeks	—

Secondary

Measure	Time frame
1. Changes in Non-HDL, HDL-C, Triglyceride, hs-CRP, CPK 2. Hepatic, Renal and Cardiac safety 3. Tolerability Timepoint: 24 weeks	—

Countries

India

Contacts

Public ContactDr Dipanwita Sarkar

Burdwan Medical College

dipanwitame1@gmail.com9674195989

Outcome results

None listed

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