Health Condition 1: I159- Secondary hypertension, unspecified
Conditions
Interventions
Intervention1: Esaxerenone 5mg: One Tablet will be date for 84 days
Control Intervention1: Eplerenone 50mg: One Tablet will be date for 84 days
Sponsors
ERIS LIFESCIENCES LIMITED
ERIS LIFESCIENCES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean seated systolic blood pressure SBP Change from baseline in mean seated diastolic blood pressure DBP Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean seated systolic blood pressure SBPTimepoint: 4 and 8 weeks;Change from baseline in mean seated diastolic blood pressure DBPTimepoint: 4 and 8 weeks;Percentage of the subjects achieved the target levels of clinical SBPTimepoint: 4, 8 and 12 weeks;Percentage of the subjects achieved the target levels of clinical DBPTimepoint: 4, 8 and 12 weeks;Proportion of respondersTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed