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

Hansung University

Status and phase: Completed; Phase 4

Conditions: Hypertension,Essential; Hyperuricemia

Treatments: Drug: Losartan; Drug: Aliskiren

Study type: Interventional

Funder types: Other

Identifiers

NCT06718062

KY20241128-01

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 37 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with Hypertension
2. Diagnosed with Hyperuricemia
3. Serum uric acid levels between 420 μmol/L and 700 μmol/L
4. Age between 18 and 80 years
5. Able to provide informed consent
6. No history of gout
7. No serious comorbidities such as severe kidney, liver, or cardiovascular diseases

Exclusion criteria

1. Diagnosis of Gout
2. History of secondary hypertension
3. Severe organ dysfunction, including liver, kidney, or heart failure
4. History of malignant tumors
5. Severe cognitive disorders or mental illness
6. Pregnant or breastfeeding women
7. Allergy to study medications (Aliskiren or Losartan)
8. Participation in other clinical trials during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups, including a placebo group

Aliskiren Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Aliskiren

Losartan Group

Active Comparator group

Description:

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.

Treatment:

Drug: Losartan