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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Hypertension,Essential
• Intervention / Treatment: Drug: Aliskiren; Drug: Losartan

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Chancheng District People's Hospital, Foshan City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure	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.	Baseline (before treatment) and 3 months
Change in Kidney Function	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).	Baseline (before treatment) and 3 months

Collaborators and Investigators

• Sponsor: Hansung University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Hyperuricemia; Non-inferiority
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Essential Hypertension; Hypertension; Hyperuricemia; Renin Inhibitors; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan; Aliskiren
• Other Study ID Numbers: KY20241128-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No