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CTRI Number  CTRI/2025/04/084658 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 30/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An evaluation of efficacy and safety of Statin versus Bempedoic acid versus Bempedoic acid added Ezetemibe in dyslipidemic North Indian population. 
Scientific Title of Study   An evaluation of efficacy and safety of Statin versus Bempedoic acid versus Bempedoic acid plus Ezetemibe in dyslipidemic North Indian population at tertiary care centre. 
Trial Acronym  BEMPE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ved Prakash 
Designation  Assistant professor 
Affiliation  IMS-BHU Varanasi 
Address  Department of Pharmacology IMS-BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8601741409  
Fax    
Email  sonivedgmc@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Ved Prakash 
Designation  Assistant professor 
Affiliation  IMS-BHU Varanasi 
Address  Department of Pharmacology IMS-BHU Varanasi


UTTAR PRADESH
221005
India 
Phone  8601741409  
Fax    
Email  sonivedgmc@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Ved Prakash 
Designation  Assistant professor 
Affiliation  IMS-BHU Varanasi 
Address  Department of Pharmacology IMS-BHU Varanasi


UTTAR PRADESH
221005
India 
Phone  8601741409  
Fax    
Email  sonivedgmc@bhu.ac.in  
 
Source of Monetary or Material Support  
Director, IMS-BHU, Varanasi, 221005, uttar pradesh, India 
 
Primary Sponsor  
Name  Institute of Medical Sciences Banaras Hindu University 
Address  Department of Pharmacology IMS-BHU Lanka varanasi-221005 Uttar Pradesh India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ved Prakash  Sir sunderlal hospital-BHU  Cardiology Department & Medicine department Sir Sunderlal hospital Banaras Hindu University Lanka Varanasi 22105 India
Varanasi
UTTAR PRADESH 		 8601741409

sonivedgmc@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E782||Mixed hyperlipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Statin versus Bempedoic acid versus Bempedoic acid plus Ezetemibe   Dyslipdemic patients will be divided in 3 groups. Gp 1 will be given Statin. Gp 2 will be given Bempedoic acid. Gp 3 will be given Bempedoic acid with Ezetimide. The investigations will be done at baseline, 4, 8 and 12 weeks for dyslipidemia and the result will be statistically compared  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  dyslipidemic patients 
 
ExclusionCriteria 
Details  pregnancy, lactation, renal failure, severe hepatic dysfunction, neurological disorders, on immunosuppressants  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
lipid profile, hsCRP, CPK-total, HbA1c. BMI, LFT, RFT.  base line , 4 , 8 and 12 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
   
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonivedgmc@bhu.ac.in].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Dyslipdemia is a global health concern due to major cardiovascular impact . statins are the corner stone of prevention and treatment of Cardiovascular disease but can produce statin associated muscle weakness. there is no universally accepted defination  for statin intolerance. Statin associated muscle symptoms are an important clinical problem, causing discontinuation of treatment leading to harmful impact on health. the present study will compare the efficacy and safety of Bempedoic acid  monotherapy (180mg daily dose) and fixed dose combination Bempedoic acid with Ezetimibe versus statin (10mg). 
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