A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 62
- 主要终点
- Change From Baseline in Mean Seated Systolic BP (SBP)
研究概览
简要总结
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.
Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
- •Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
- •Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
- •If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
- •Agrees to comply with the contraception and reproduction restrictions of the study;
排除标准
- •Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
- •Has a body mass index (BMI) >50 kg/m2;
- •Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
- •Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
- •Has documented estimated eGFR <30 mL/min/1.73m2;
- •Has known and documented New York Heart Association stage III or IV chronic heart failure;
- •Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
- •Major cardiac surgery within 6 months before Screening;
- •Has chronic permanent atrial fibrillation;
- •Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
- •Has planned dialysis or kidney transplantation planned during the course of the study;
- •Prior solid organ transplant and/or cell transplants;
- •Sodium <130 mEq/L;
- •Potassium <3.5 mEq/L;
- •Potassium >5 mEq/L;
- •White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
- •Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
- •Has typical consumption of ≥14 alcoholic drinks weekly;
研究组 & 干预措施
CIN-107 0.5 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
干预措施: CIN-107 (Drug)
CIN-107 1 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
干预措施: CIN-107 (Drug)
CIN-107 2 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
干预措施: CIN-107 (Drug)
Placebo
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Seated Systolic BP (SBP)
时间窗: 8 weeks
The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).
次要结局
- Change From Baseline in Mean Seated Diastolic BP (DBP)(8 weeks)
- Change From Baseline in 24-hour Urine Aldosterone(8 weeks)
- Change From Baseline in 24-hour Serum Renin(8 weeks)
- Change From Baseline in 24-hour Serum Aldosterone(8 weeks)
- Percentage of Patients Achieving a Mean Seated SBP <130 mmHg(8 weeks)
- Change From Baseline in 24-hour Urine Renin(8 weeks)