A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 80
- 主要终点
- Change From Baseline in Mean Seated Systolic BP (SBP)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).
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 ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;
- •Be at least 70% compliant to their anti-hypertensive medication regimen;
- •Has a seated BP ≥ 130/80 mmHg;
- •Agrees to comply with the contraception and reproduction restrictions of the study; and
- •Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.
排除标准
- •Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
- •Has a body mass index (BMI) > 40 kg/m2;
- •Has an upper arm circumference < 7 or > 17 inches;
- •Has been on night shifts at any time during the 4 weeks before Screening;
- •Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
- •Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
- •Is not willing or not able to discontinue taking a potassium supplement;
- •Has documented estimated glomerular filtration rate (eGFR) < 45 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;
- •Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
- •Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
- •Has chronic permanent atrial fibrillation;
- •Has uncontrolled diabetes with glycosylated hemoglobin > 9.5% at Screening;
- •Has planned dialysis or kidney transplant during the course of this study;
- •Potassium < 3.5 mEq/L;
- •Potassium > 5.0 mEq/L;
- •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 0.5mg
Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
干预措施: CIN-107 (Drug)
CIN-107 1mg
Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
干预措施: CIN-107 (Drug)
CIN-107 2mg
Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
干预措施: CIN-107 (Drug)
Placebo
Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
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: 12 weeks
次要结局
- Change From Baseline in Mean Seated Diastolic BP (DBP)(12 weeks)
- The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg(12 weeks)