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

NCT06718062 | Completed Phase 4

• 1 other identifier: KY20241128-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypertension; Hyperuricemia; Non-inferiority

Outcome Measures

Primary Outcomes (1)

• Change in Serum Uric Acid Levels

  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.

  Baseline (before treatment) and 3 months

Secondary Outcomes (2)

• Change in Blood Pressure

  Baseline (before treatment) and 3 months

• Change in Kidney Function

  Baseline (before treatment) and 3 months

Study Arms (2)

Aliskiren Group

PLACEBO COMPARATOR

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.

Drug: Aliskiren

Losartan Group

ACTIVE COMPARATOR

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.

Drug: Losartan

Interventions

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.

Aliskiren Group

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.

Losartan Group

Eligibility Criteria

• Age: 37 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansung University: lead

Study Sites (1)

Chancheng District People's Hospital, Foshan City

Foshan, Guangdong, China

Location

MeSH Terms

Conditions

Essential Hypertension; Hyperuricemia; Hypertension

Interventions

aliskiren; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (1)