Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: 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, t
Sponsors
Sun Pharma Laboratories Limited
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SBPTimepoint: Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SBPTimepoint: Baseline, Weeks 2, 4, 6, and 8;Change in DBPTimepoint: Baseline, Weeks 2, 4, 6, 8 and 12;Proportion of patients achieving targeted sitting BP (less than 140/90 mm Hg) at Week 12Timepoint: Week 12;Change from baseline in 36-Item Short Form Health Survey questionnaire (SF-36) total scoreTimepoint: Baseline, Weeks 4, 8, and 12;Incidence of TEAEsTimepoint: Timeframe: Baseline, Weeks 4, 8, and 12 | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed