Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- eGFR
研究概览
简要总结
This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.
详细描述
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADPKD patients
- •Blood pressure measured at out-patient setting is above 120/80 mmHg
- •Age between 20 and 60 years old
- •eGFR more than 30 ml/min/1.73m2
- •Patients give informed consent
排除标准
- •Patients with severe cardiovascular and hepatic disorders
- •Patients with complications of central nervous vascular disorders
- •Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
- •Patients currently engaging in other experimental protocol
- •Patients with intracranial aneurysma
- •Patients who must use diuretics
- •Allergic patients to Candesartan or Cilnidipine
- •Patients whose hypertension is not controlled by medication of this protocol
研究组 & 干预措施
Cilnidipine
The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine.
干预措施: Cilnidipine (Drug)
Imidapril
The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril.
干预措施: Imidapril (Drug)
结局指标
主要结局
eGFR
时间窗: every 6 months
次要结局
- Kidney Volume measured by MRI(every 3 months to every 2 years)
- Serum creatinine level(every 3 months to every 2 years)
- Induction of hemodialysis, cardiovascular events and central nervous vascular events(every 3 months to every 2 years)