Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Serum Uric Acid Levels
研究概览
简要总结
This clinical trial aims to evaluate the non-inferiority of Aliskiren compared to Losartan in the treatment of hypertension combined with hyperuricemia. Hypertension and hyperuricemia often coexist and may exacerbate each other, increasing the risk of cardiovascular and renal complications. Both Aliskiren and Losartan are widely used for managing hypertension, but their effects on serum uric acid levels and renal function are not well understood in this patient population.
This study will involve 66 participants, randomly assigned to receive either Aliskiren (240 mg daily) or Losartan (100 mg daily) for a treatment period of 3 months. The primary outcome will be the change in serum uric acid levels before and after treatment. Secondary outcomes include changes in blood pressure, kidney function (measured by creatinine levels, eGFR), and adverse events.
The primary objective is to demonstrate that Aliskiren is non-inferior to Losartan in lowering serum uric acid levels. Additionally, the study will assess whether Aliskiren, while effectively managing blood pressure, has a lesser impact on kidney function compared to Losartan.
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
- 37 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Hypertension
- •Diagnosed with Hyperuricemia
- •Serum uric acid levels between 420 μmol/L and 700 μmol/L
- •Age between 18 and 80 years
- •Able to provide informed consent
- •No history of gout
- •No serious comorbidities such as severe kidney, liver, or cardiovascular diseases
排除标准
- •Diagnosis of Gout
- •History of secondary hypertension
- •Severe organ dysfunction, including liver, kidney, or heart failure
- •History of malignant tumors
- •Severe cognitive disorders or mental illness
- •Pregnant or breastfeeding women
- •Allergy to study medications (Aliskiren or Losartan)
- •Participation in other clinical trials during the study period
研究组 & 干预措施
Aliskiren Group
Participants in this group will receive Aliskiren (240 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be provided by Shenzhen Xinlitai Pharmaceutical Co., Ltd., with the approval number National Drug Approval No. H20138002. The patients will take Aliskiren orally once a day for 3 months. The primary objective is to assess the non-inferiority of Aliskiren in lowering serum uric acid levels, as well as its effects on blood pressure and kidney function.
干预措施: Aliskiren (Drug)
Losartan Group
Participants in this group will receive Losartan (100 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be provided by Zhejiang Huahai Pharmaceutical Co., Ltd., with the approval number National Drug Approval No. H20143030. The patients will take Losartan orally once a day for 3 months. The goal is to compare the efficacy of Losartan in reducing serum uric acid levels with Aliskiren and evaluate its impact on blood pressure and kidney function.
干预措施: Losartan (Drug)
结局指标
主要结局
Change in Serum Uric Acid Levels
时间窗: Baseline (before treatment) and 3 months
The primary outcome measure is the change in serum uric acid levels from baseline to the end of treatment (3 months) in both the Aliskiren and Losartan treatment groups. Serum uric acid levels will be measured using the uricase method from 5 mL fasting venous blood samples before and after treatment. This measure will assess the non-inferiority of Aliskiren compared to Losartan in lowering serum uric acid levels in patients with hypertension and hyperuricemia.
次要结局
- Change in Blood Pressure(Baseline (before treatment) and 3 months)
- Change in Kidney Function(Baseline (before treatment) and 3 months)