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NCT Number: NCT06718062

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

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

37 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chancheng District People's Hospital, Foshan City

Foshan, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Aliskiren

Drug

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.

Losartan

Drug

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.

Primary outcomes

  1. Change in Serum Uric Acid Levels

    Time frame: 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.

Secondary outcomes

  1. Change in Blood Pressure

    Time frame: Baseline (before treatment) and 3 months

    The secondary outcome measure is the change in blood pressure (systolic and diastolic) from baseline to the end of treatment (3 months). Blood pressure will be measured using a sphygmomanometer after the participant has rested for at least 5 minutes, with three measurements taken at 1-minute intervals and the average value used.

  2. Change in Kidney Function

    Time frame: Baseline (before treatment) and 3 months

    Change in Kidney Function The secondary outcome measure is the change in kidney function, creatinine (Cr) ， from baseline to the end of treatment (3 months).

Sponsors and collaborators

Lead sponsor

Hansung University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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