NCT00353574终止3 期
DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study 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-E)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 282
- 试验地点
- 74
- 主要终点
- Change in trough sitting systolic and diastolic blood pressure
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 United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, 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 have completed the Treatment Period of clinical trial DAR-311
- •Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
排除标准
- •Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
- •Treatment with another endothelin receptor antagonist within 6 months of study entry
研究组 & 干预措施
Darusentan 50 mg
Experimental
Darusentan 50 mg administered orally once daily
干预措施: Darusentan (Drug)
Darusentan 100 mg
Experimental
Darusentan 100 mg administered orally once daily
干预措施: Darusentan (Drug)
Darusentan 300 mg
Experimental
Darusentan 300 mg administered orally once daily
干预措施: Darusentan (Drug)
结局指标
主要结局
Change in trough sitting systolic and diastolic blood pressure
时间窗: Baseline to Week 14
次要结局
- Change in mean 24-hour systolic and diastolic ambulatory blood pressures.(Baseline to Week 14)
- Percentage of subjects who reach systolic blood pressure goal(Week 14)
- Change in estimated glomerular filtration rate (eGFR)(Baseline to Week 14)
研究者
研究点 (74)
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不适用
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