NCT04162366撤回3 期
Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
研究概览
简要总结
The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months).
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
- •Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
- •Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation),
- •Women of childbearing potential are eligible only if the following applies:
- •Negative pregnancy test at the screening visit and at baseline (i.e., end of run-in period).
- •Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation.
- •Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation.
排除标准
- •Mean sitting systolic blood pressure above 170 mmHg measured by "automated office blood pressure measurement" (AOBPM),
- •Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
- •Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the screening visit,
- •Planned dialysis or kidney transplant during the course of this study,
- •Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g,
- •Known and documented chronic heart failure.
研究组 & 干预措施
Aprocitentan 25 mg
Experimental
干预措施: Aprocitentan 25 mg (Drug)
Placebo
Experimental
干预措施: Placebo (Drug)
Aprocitentan 25 mg or Placebo
Experimental
干预措施: Aprocitentan 25 mg (Drug)
Aprocitentan 25 mg or Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
时间窗: From baseline to Week 4 after treatment initiation
次要结局
- Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.(From baseline to Week 4 after treatment initiation)
- Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4(From baseline to Week 4 after treatment initiation)
研究者
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