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 Uncontrolledor Resistant Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 19
- 主要终点
- Change in SBP
研究概览
简要总结
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
of investigational product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- 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
- •Patients of either gender, aged between 18 to 65 years (both inclusive) and willing to provide written informed consent.
- •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.
- •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.
- •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.
- •Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above.
排除标准
- •Known allergy or sensitivity to the study intervention or any of its components
- •History of or presence of secondary hypertension as determined by Investigator
- •Presence of severe hypertension or malignant hypertension with or without hypertensive retinopathy
- •Serum potassium level less than 3.5 or greater than or equal to 5 mEq/L
- •Reversed day night life cycle including overnight workers
- •Known cardiovascular disease within the previous 6 months of screening
- •Cerebrovascular disease within 6 months of screening.
- •Patients with left bundle branch block and any cardiac arrythmia
- •Patients with family history of long QT
- •Patients with QTcF greater than 470 msec at screening
- •Patients with history of adrenal insufficiency
- •History of hospitalization for hyperkalaemia within one year of screening
- •History of a significant adverse drug reactions (e.g., electrolyte abnormality and acute renal failure) to spironolactone or eplerenone
- •Regular use of any systemic medication that may affect blood pressure not to be taken within 24 hrs of clinic visit.
- •Patients who will/may require concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)
- •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
- •Patients receiving Potassium binders within 2 months of screening
- •Patients receiving systemic corticosteroid or immunosuppressants within 4 weeks of screening
- •Patients with inadequate liver function at Screening
- •Serum Sodium less than 135 mmol/L at screening.
- •Hypersensitivity to Study medications, any other excipients, or steriods such as cortisones, estrogen and progesterone
- •Patient with severe obesity (body mass index [BMI] greater than 37 kg/m2) at Screening
- •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.
- •Pregnancy and lactation
- •Participants with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
- •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
- •Patient with history of participation in another clinical trial in the past 3 months of Screening.
结局指标
主要结局
Change in SBP
时间窗: Baseline, Week 12
次要结局
- 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)
- 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)