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CTRI Number  CTRI/2025/02/080030 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 27/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to evaluate the efficacy of Esaxerenone in patients with hypertension  
Scientific Title of Study   A Multicentric, Randomized, Prospective, Double Blind, Parallel Group, Comparative, Active Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety And Tolerability Of Esaxerenone 5mg Versus Eplerenone 50mg In Patients With Uncontrolled Or Resistant Hypertension. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICS/ERI/2024-003 Version 1.0 Date 10 May 2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Kartik Sahni  
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura

North West
DELHI
110034
India 
Phone  9868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kartik Sahni  
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura


DELHI
110034
India 
Phone  9868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Public Query  
Name  Mr Ganesh Boddu 
Designation  Head-Clinical and Regulatory Affairs 
Affiliation  Eris Lifesciences Limited 
Address  Department of Clinical and Regulatory Affairs Opp Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej

Ahmadabad
GUJARAT
380059
India 
Phone  7969661401  
Fax    
Email  ganesh.boddu@erislifesciences.com  
 
Source of Monetary or Material Support  
ERIS LIFESCIENCES LIMITED, Opp. Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej, Ahmedabad, Gujarat, 380059 
 
Primary Sponsor  
Name  ERIS LIFESCIENCES LIMITED  
Address  1st Floor, 101 Shivarth Ambit, Opp Janvi Bunglows Nr Mann Party Plot Sidhubhavan Road, Bodakdev Ahmedabad India 380054 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
ERIS LIFESCIENCES LIMITED   Opp. Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej, Ahmedabad, Gujarat, 380059 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kamaldeep Y Chawla  Aman Hospital and Research Centre  15, Shashwat, Opp, ESI Hospital, Gotri Road-390021
Vadodara
GUJARAT 		 9898235393

kychawla@rediffmail.com 
Dr Naresh Munot  CIMETS Inmadar Multispecialty Hospital  S.No. 15, Behind KPCT Mall, Fatima Nagar, Wanawadi, Pune, Maharashtra-411040
Pune
MAHARASHTRA 		 9421018261

dr.nareshmunot@gmail.com 
Dr P Haribabu  Government Medical College & Government General Hospital  (Old RIMSGGH), Department of Cardiology, Research Wing, 2nd Floor, Beside FM Ward-532001.
Srikakulam
ANDHRA PRADESH 		 8942279033

gghsrikakulam@gmail.com 
Dr Hitendra Bhagwatkar  NKP Salve Institute of Medical Science & Research Centre and Lata Mangeshkar Hospital  Hrudayaa Cardiac and Vascular Care Centre, Unit of Hingna Road, Digdoh Hills, Nagpur, Maharashtra-440019
Nagpur
MAHARASHTRA 		 9096115922

hitendrabhagwatkar@gmail.com 
Dr Giriraja KV  Rajalakshmi Hospital and Research Cenre   #21/1 Lakshmipura Main Road, Vidyaranyapura post, Bangalore-560097
Bangalore
KARNATAKA 		 9448039952

drgirirajakv@gmail.com 
Dr Ganesh Manudhane  Sevenhills Healthcare Pvt Ltd  Level 2, Block 10. Marol Maroshi Rd, Mahavir Nagar, Pandit Dindayal Upadhayay Nagar, Andheri East-400059
Mumbai
MAHARASHTRA 		 7276705766

drganeshmanudhane@gmail.com 
Dr Prashant Pawar  Signus Hospital   Research Department, Room No 4, 5th Floor Atlanta Shoppers, Signus Hospital Pathardi Phata 422010
Nashik
MAHARASHTRA 		 9623195719

drprashantpawar63@gmail.com 
Dr Zohaib Shaikh  Sion Hospital  Department of Cardiology, Lokmanya Tilak Municipal Medical College & General Hospital Building,2nd floor, Room no.2 -400022
Mumbai
MAHARASHTRA 		 9869286469

dezohaibshaikh@gmail.com 
Dr Laxmikant Goyal  SMS Medical College and Attached Hospital  JLN Road, Jaipur-302004
Jaipur
RAJASTHAN 		 7597028028

drlkgoyal@gmail.com 
Dr Pankaj Harkut  Swasthyam Hospital  Plot no. 97,98, CTO Staff Co-operative Housing Society Vivekanand nagar, near sai mandir, Wardha road, Nagpur-440015
Nagpur
MAHARASHTRA 		 9372723376

pankajharkut@rediffmail.com 
Dr K Bhargavi  Vijaya Superspeciality Hospital  OPD Room NO: 04 16 -II/41 A, Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh -524001, India
Nellore
ANDHRA PRADESH 		 9885891311

bhargavi@pcripl.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee of Inamdar Multispecialty Hospital  Approved 
Ethics Committee of SMS Medical College & Attached Hospital, Jaipur  Approved 
IEC Aman Hospital and Research Center   Approved 
IEC NKP Salve of Medical Science & Research Centre and Lata Mangeshkar Hospital  Approved 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital   Approved 
Institutional Ethics Committee-Staff & Research Society  Approved 
Medical Ethics Committee Sevenhills Sevenhills Healthcare Pvt Ltd   Approved 
PCRI Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
Signus Hospital Ethics Committee  Approved 
Swasthyam Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I159||Secondary hypertension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Eplerenone 50mg   One Tablet will be date for 84 days  
Intervention  Esaxerenone 5mg   One Tablet will be date for 84 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Willing to give consent to participate
2.Female or male aged 18 to 65 both inclusive years at the time of consent.
3.Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study and who have a negative urine pregnancy test.
4.Subjects must fulfill at least 1 of the following 2 criteria
i. Uncontrolled hypertension Subject on a stable regimen of 2 antihypertensive medications, from different therapeutic classes at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to Screening. Beta blockers used to treat other conditions should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
ii. Resistant hypertension have a stable regimen of more than 3 antihypertensive medications, from different therapeutic classes at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to Screening. Beta blockers used to treat other conditions (i.e., migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.

5. Must demonstrate a mean seated SBP more than 140-179 and DBP more than 90-109 mmHg
[Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit. Patients may have mean seated BP less 140 by 90 mmHg at Screening if taking an MRA as part of their antihypertensive regimen however, the a mean seated SBP more than 140-179 and DBP more than 90-109 mmHg at re-screening visit after discontinuing the MRA, with or without replacement medication].
6.Estimated glomerular filtration rate more than 45 mLperminper1.73m2 at Screening.
7.Serum potassium level more than 3.5 and less than 5.1 mmol/L at Screening.
8.Have no change in background therapy regimen and dose consisting of either 2 antihypertensive medications for participants in the uHTN subpopulation, or more than 3 antihypertensive medications (at least one should be a diuretic) for participants in the rHTN subpopulation, for at least 4 weeks prior to screening (participants who do not meet this criterion may be rescreened at the Investigator’s discretion, Beta blockers used to treat other conditions (i.e., migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
9.In case of females, non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females. 
 
ExclusionCriteria 
Details  1. Has a mean seated SBP more than 180 mmHg or DBP more than 110 mmHg at Screening;
2.Body mass index more than 40 kg per m2 at Screening;
3. Subjects previously sensitive to any of the ingredients of the investigational products.
4. Subjects with a known history of secondary or malignant hypertension.
5.Subjects taking potassium supplements.
6.Subjects with EF less than 40 percent as per Simpsons method on 2D Echo.
7.New York Heart Association class IV Congestive Heart Failure.
8. MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment.
9. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair or replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization.
10.Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigators clinical judgement.
11.Active malignancy requiring treatment at the time of visit 1.
12.Hepatic impairment.
13.Renal Impairment (eGFR less than 45 mL/min per 1.73m2, S. Creatinine values and S.BUN ULN).
14.Type 1 Diabetes Mellitus or uncontrolled Type 2 DM.
15.Microalbuminuria (UACR more than 200 on Spot UACR testing at Visit 1).
16.Subjects otherwise judged to be inappropriate for inclusion in the study by the investigators judgment.
17.Subjects with known alcohol or drug abuse history.
18.Subjects with known History or positive testing of HIV, Hepatitis B and C.
19.Known blood-borne diseases.
20.Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
21.Participation in another clinical study with an IP during the last month prior to enrolment.
22.Inability of the patient, in the opinion of the investigator, to understand and or comply with IP, procedures and or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in mean seated systolic blood pressure SBP
Change from baseline in mean seated diastolic blood pressure DBP
 		 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in mean seated systolic blood pressure SBP   4 and 8 weeks 
Change from baseline in mean seated diastolic blood pressure DBP  4 and 8 weeks 
Percentage of the subjects achieved the target levels of clinical SBP   4, 8 and 12 weeks 
Percentage of the subjects achieved the target levels of clinical DBP  4, 8 and 12 weeks 
Proportion of responders  12 weeks 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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 3 
Date of First Enrollment (India)   13/02/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Most resistant hypertension can be controlled with the addition of more medications and higher medication doses in addition to lifestyle management. Lifestyle changes should include a reduction of sodium intake to below 100 mmol/day, alcohol intake of fewer than 14 drinks/week for men and 10/week for women, as well as regular exercise. For those with obstructive sleep apnea, in addition to these lifestyle measures, continuous positive airway pressure may also be of benefit

A mineralocorticoid receptor antagonist (MRA) or aldosterone antagonist, is a diuretic drug which antagonizes the action of aldosterone at mineralocorticoid receptors. Aldosterone is a mineralocorticoid hormone that being profibrotic contributes to deleterious processes in various organs of the body including the heart. Signaling via mineralocorticoid receptor regulates salt and water balance, but also prompts inflammation, vasoconstriction, and oxidative stress, which ultimately leads to tissue fibrosis

This will be a multi-centric, randomized, prospective, double-blind, parallel-group, comparative active-controlled Phase III clinical trial to evaluate the efficacy, safety and tolerability of Esaxerenone 5mg Tablets versus Eplerenone 50mg Tablets in Patients with uncontrolled or resistant hypertension.


 
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