DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 114
- 主要终点
- Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
研究概览
简要总结
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are competent to provide written consent
- •Aged 35 to 80 years
- •Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
- •All other subjects must have a mean systolic blood pressure ≥140 mmHg
- •Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
- •Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
排除标准
- •Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- •Serum ALT or AST >2 x the upper limit of the normal range (ULN)
- •Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
- •Implanted pacemakers or implanted cardioverter defibrillator (ICD)
- •Symptomatic congestive heart failure requiring treatment
- •Hemodynamically significant valvular heart disease
- •Type I diabetes mellitus
- •Hemodialysis or peritoneal dialysis; or history of renal transplant
- •Diagnosis or recurrence of malignancy within the past 3 years
- •Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
- •Subjects who perform alternating shift or night work
- •Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
研究组 & 干预措施
Darusentan Placebo
Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
Darusentan 50 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
干预措施: Darusentan (Drug)
Darusentan 50 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
Darusentan 100 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
干预措施: Darusentan (Drug)
Darusentan 100 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
Darusentan 300 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
Darusentan 300 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
干预措施: Darusentan (Drug)
结局指标
主要结局
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
时间窗: Baseline to Week 14
次要结局
- Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure(Baseline to Week 14)
- Percentage of subjects to reach systolic blood pressure goal(Week 14)
- Change from baseline in estimated glomerular filtration rate (eGFR)(Baseline to Week 14)