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NCT06718062CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
66 (actual)
First submitted
28 Nov 2024
Start date
1 May 2021
Primary completion date
1 May 2024
Lead sponsor
Hansung University
NCT number
NCT06718062

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 66
  • From 1 May 2021 to the primary completion date, 1 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of secondary hypertension
  • Severe organ dysfunction, including liver, kidney, or heart failure
  • History of malignant tumors
  • Severe cognitive disorders or mental illness
  • Allergy to study medications (Aliskiren or Losartan)

Other

  • Diagnosis of Gout
  • Pregnant or breastfeeding women
  • Participation in other clinical trials during the study period

Who the study is looking for

  • 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

Age in the registry: 37 years to 81 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chancheng District People's Hospital, Foshan City
Coordinator of this site? Confirm its status
FoshanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.