A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 849
- 试验地点
- 145
- 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 randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Darusentan
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks
干预措施: Darusentan (Drug)
Darusentan
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
Guanfacine
Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks
干预措施: Guanfacine (Drug)
Guanfacine
Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks
干预措施: Darusentan Placebo (Drug)
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)
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
- Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment(Week 14)
- Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)(Baseline to Week 14)
- Change from baseline in estimated glomerular filtration rate (eGFR)(Baseline to Week 14)