NCT06718062

Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hansung University · Academic / Other
• Sex: All
• Age: 37 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertension,Essential
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Aliskiren	Participants in this group will receive Aliskiren (240 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be administered orally once a day for 3 months. The drug will be provided by Shenzhen Xinlitai Pharmaceutical Co., Ltd., with the National Drug Approval No. H20138002. The primary objective is to evaluate the non-inferiority of Aliskiren in lowering serum uric acid levels, and its effects on blood pressure and kidney function.
DRUG	Losartan	Participants in this group will receive Losartan (100 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be administered orally once a day for 3 months. The drug will be provided by Zhejiang Huahai Pharmaceutical Co., Ltd., with the National Drug Approval No. H20143030. 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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-05-01
• Completion: 2024-10-01
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China