Hypertension,EssentialPhase 4NCT06718062
Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia
A Phase 4 study testing Aliskiren and Losartan in people with Hypertension,Essential and Hyperuricemia, run by Hansung University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 81 years
- Conditions the study is for
- Hypertension,Essential, Hyperuricemia
- What is being tested?
- Aliskiren and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Aliskiren, Losartan
- Keywords
- Hypertension, Hyperuricemia, Non-inferiority
- Medical subject headings
- Essential Hypertension, Hyperuricemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
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.
LosartanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before treatment) and 3 months
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline (before treatment) and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 May 2021
- Primary completion1 May 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718062
- Sponsor's protocol ID
- KY20241128-01
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia
- ClinicalTrials.gov ID
- NCT06718062
- Acronym / sponsor ID
- KY20241128-01
- Conditions
- Hypertension,Essential, Hyperuricemia
- Keywords
- Hypertension, Hyperuricemia, Non-inferiority
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hansung UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren Group | Placebo comparator | Drug: AliskirenParticipants 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. |
| Losartan Group | Active comparator | Drug: LosartanParticipants 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. |
Who may qualify
- Ages
- 37 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliskirenParticipants 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. | Drug | Aliskiren Group |
| LosartanParticipants 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. | Drug | Losartan Group |
Primary outcome
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.
2 secondary outcomes
Change in Blood Pressure
Time frame: Baseline (before treatment) and 3 months
Change in Kidney Function
Time frame: Baseline (before treatment) and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and Losartan in people with Hypertension,Essential and Hyperuricemia, run by Hansung University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Uric Acid Levels (time frame: Baseline (before treatment) and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.