CTRI/2025/02/080030进行中（未招募）3 期
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.
ERIS LIFESCIENCES LIMITED11 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年2月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 11
- 主要终点
- Change from baseline in mean seated systolic blood pressure SBP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Change from baseline in mean seated systolic blood pressure SBP
时间窗: 12 weeks
Change from baseline in mean seated diastolic blood pressure DBP
时间窗: 12 weeks
次要结局
- 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)
研究者
Mr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
研究点 (11)
Loading locations...
相似试验
已完成
3 期
A Clinical Trial to determine the efficacy and safety of Fixed-Dose Combination of Bisoprolol 5mg and Cilnidipine 10mg Tablet in patients with Essential Hypertension.CTRI/2025/07/092103Unique Pharmaceutical Laboratories (a Division of J. B. Chemicals & Pharmaceuticals Ltd.)214
尚未招募
3 期
Management of Resistant Hypertension through HomoeopathyCTRI/2025/07/090537Central Council for Research in Homoeopathy, New Delhi, India100
尚未招募
2/3 期
Management of Hypertension through AyurvedaCTRI/2025/03/081817Ayurvedic and Unani Tibbia College and Hospital60
尚未招募
不适用
Managing the primary hypertension in adults with individualized dynamized homoeopathic medicine - A prospective studyCTRI/2025/09/094729Sainath Homoeopathic Hospital50
尚未招募
2 期
A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential HypertensionNCT07373613Boryung Pharmaceutical Co., Ltd330