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.
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- ERIS LIFESCIENCES LIMITED
- Enrollment
- 204
- Locations
- 11
- Primary Endpoint
- Change from baseline in mean seated systolic blood pressure SBP
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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.
- •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.
- •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.
Exclusion Criteria
- •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;
- •Subjects previously sensitive to any of the ingredients of the investigational products.
- •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.
- •MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment.
- •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
Outcomes
Primary Outcomes
Change from baseline in mean seated systolic blood pressure SBP
Time Frame: 12 weeks
Change from baseline in mean seated diastolic blood pressure DBP
Time Frame: 12 weeks
Secondary Outcomes
- 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)
Investigators
Mr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.