CTRI/2025/05/087278 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On:
27/02/2026
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 Study to Evaluate the effect and Safety of Esaxerenone Tablets for Treatment of participants with Uncontrolled or Resistant Hypertension
Scientific Title of Study
A Prospective, Multicenter, Randomized, Assessor-Blind, Parallel-Group, Active-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Esaxerenone Tablets for Treatment of Uncontrolled
or Resistant Hypertension
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/24/016, Version No. 1.0; Dated 10/DEC/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban), MAHARASHTRA
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Medical Monitor-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban), MAHARASHTRA
400063, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban), MAHARASHTRA
400063, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400063
India
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA 400063 India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara, Gujarat 390012
Oral tablets once daily.
Starting dose of Eplerenone Tablets is 50 mg administered once daily. If
inadequate blood pressure response is
noted by 4 weeks, then increase the
dosage of Eplerenone tablets to 50 mg twice daily from Week 4.
Intervention
Esaxerenone Tablets 2.5 mg and 5 mg
The usual adult dosage is 2.5 mg of Esaxerenone Tablets administered orally once daily. If inadequate blood pressure
response is noted by 4 weeks, the dose can
be increased up to 5 mg from Week 4.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender, aged between 18 to 65 years (both inclusive) and willing to provide written informed consent.
2. Patients of uncontrolled hypertension who are on a stable regimen of greater than or equal to 2 antihypertensive medications, from different therapeutic classes at optimal or maximum tolerated dose as per Investigator’s discretion for at least 4 weeks before randomization
OR
Patients of resistant hypertension who are on a stable regimen of greater than or equal to 3 antihypertensive medications, from different therapeutic classes at optimal or maximum tolerated dose as per Investigator’s discretion for at least 4 weeks before randomization.
3. Patients, having systolic blood pressure (SBP) greater than or equal to 140 mm Hg and less than 180 mm Hg and diastolic blood pressure (DBP) greater than or equal to 90 mm Hg and less than 110 mmHg at screening and randomization.
4. Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of the study.
5. Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above.
ExclusionCriteria
Details
1. Known allergy or sensitivity to the study intervention or any of its components
2. History of or presence of secondary hypertension as determined by Investigator
3. Presence of severe hypertension or malignant hypertension with or without hypertensive retinopathy
4. Serum potassium level less than 3.5 or greater than or equal to 5 mEq/L
5. Reversed day night life cycle including overnight workers
6. Patients with estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2.
7. Known cardiovascular disease within the previous 6 months of screening
8. Cerebrovascular disease within 6 months of screening.
9. Patients with left bundle branch block and any cardiac arrythmia
10. Patients with family history of long QT
11. Patients with QTcF greater than 470 msec at screening
12. Patients with history of adrenal insufficiency
13. History of hospitalization for hyperkalaemia within one year of screening
14. History of a significant adverse drug reactions (e.g., electrolyte abnormality and acute renal failure) to spironolactone or eplerenone
15. Regular use of any systemic medication that may affect blood pressure not to be taken within 24 hrs of clinic visit.
16. Patients who will/may require concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)
17. Patients taking mineralocorticoid receptor antagonists (MRAs), antiarrythmic drugs, potassium sparring diuretics, potassium supplements/any potassium preparation, herbal medicines for hypertension, strong cytochrome P450 (CYP) 3A inducers and inhibitors within 4 weeks of screening
18. Patients receiving Potassium binders within 2 months of screening
19. Patients receiving cytotoxic therapy within 6 months of screening
20. Patients receiving systemic corticosteroid or immunosuppressants within 4 weeks of screening
21. Patients with inadequate liver function at Screening
22. Serum Sodium less than 135 mmol/L at screening.
23. Hypersensitivity to Study medications, any other excipients, or steriods such as cortisones, estrogen and progesterone
24. Patient with severe obesity (body mass index [BMI] greater than 37 kg/m2) at Screening
25. Any clinically significant medical condition/laboratory investigations, in the opinion of the examining Investigator that may affect the safety of the participants or efficacy evaluation of the investigational product.
26. Pregnancy and lactation
27. Participants with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
28. Patient with history of nicotine and/or alcohol and/or any other substance abuse as per Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition (DSM 5) criteria within last 2 years prior to Screening
29. Patient with history of participation in another clinical trial in the past 3 months of Screening
29. Patient with history of participation in another clinical trial in the past 3 months of Screening
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Change in SBP
Baseline, Week 12
Secondary Outcome
Outcome
TimePoints
Change in SBP
Baseline, Weeks 2, 4, 6, and 8
Change in DBP
Baseline, Weeks 2, 4, 6, 8 and 12
Proportion of patients achieving targeted sitting BP (less than 140/90 mm Hg) at Week 12
Week 12
Change from baseline in 36-Item Short Form Health Survey questionnaire (SF-36) total score
Baseline, Weeks 4, 8, and 12
Incidence of TEAEs
Timeframe: Baseline, Weeks 4, 8, and 12
Target Sample Size
Total Sample Size="270" Sample Size from India="270" 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)
30/05/2025
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="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
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
This study will be a prospective, multicenter, randomized, assessor-blind, parallel-group, active-controlled, Phase III, comparative study. The study will be conducted at approximately 15 to 20 centers in India, having
qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approvals.
The participants will be screened only after obtaining written informed consent. After obtaining consent, the participants will undergo a screening period of maximum of 14 days. At screening visit, study-specific
screening including evaluation of inclusion and exclusion criteria, medical and medication history, demography, vitals, physical and eye examination will be performed. Evaluation of medications taken and
adverse events (AEs) will be done.
After confirming the eligibility, eligible participants will be randomized in 1:1 ratio to either test arm (Esaxerenone 2.5 mg) or comparator arm (Eplerenone 50 mg) by allotting the randomization number. Participants will receive either Esaxerenone 2.5 mg or Eplerenone 50 mg according to their treatment allocation.
During the treatment period, participants will be followed up at site at Week 1, Week 2, Week 4, Week 6, Week 8, and Week 12. Visit 8 will be considered EOT visit and Visit 9 will be considered as EOS visit. The efficacy and safety will be assessed during the study period. If a patient is discontinued early or terminated early, Visit 8 assessments should be performed and Visit 9 (telephonic safety follow-up) should be done 7 ± 2 days after the last dose