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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chancheng District People's Hospital, Foshan City | Foshan | Guangdong | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D033461 | Hyperuricemia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 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. |
|
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |