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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Nanchong Central Hospital | OTHER_GOV |
| The People's Hospital of Leshan | OTHER |
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This study aims to compare the efficacy and safety of Sacubitril/Valsartan versus Valsartan in patients with essential hypertension and type 2 diabetic nephropathy over a 12-week treatment period, including two treatment groups, with a total of 297 eligible subjects randomly assigned in a 2:1 ratio to either the experimental group or the control group.Subjects will participate in the study through two phases: the screening period and the follow-up period.The primary outcome measure is the change in systolic blood pressure from baseline after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Initial Dose: The starting dose of Sacubitril/Valsartan is 200 mg once daily. Dose Adjustment: If blood pressure targets (SBP < 130 mmHg and DBP < 80 mmHg) are not achieved after 2 weeks of treatment, the dose of Sacubitril/Valsartan should be doubled to 400 mg once daily. Additional Treatment: If blood pressure targets are still not met after an additional 2 weeks of treatment, Nifedipine controlled-release tablets (30 mg once daily) should be added to the regimen. |
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| Comparator | Active Comparator | Initial Dose: The starting dose of Valsartan is 80 mg once daily. Dose Adjustment: If blood pressure targets (SBP < 130 mmHg and DBP < 80 mmHg) are not achieved after 2 weeks of treatment, the dose of Valsartan should be doubled to 160 mg once daily. Additional Treatment: If blood pressure targets are still not met after an additional 2 weeks of treatment, Nifedipine controlled-release tablets (30 mg once daily) should be added to the regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril/Valsartan | Drug | Sacubitril/Valsartan is a novel antihypertensive medication composed of an angiotensin II receptor blocker (ARB) Valsartan and a neprilysin inhibitor Sacubitril in a 1:1 molar co-crystal form. Sacubitril is a prodrug that, once ingested, is metabolized by esterases into its active form, which inhibits neprilysin activity. Neprilysin has various substrates, including natriuretic peptides and angiotensin II (Ang II). By inhibiting neprilysin, the levels of natriuretic peptides that have antihypertensive and organ-protective effects are increased. The other component, Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing additional antihypertensive and organ-protective effects. The co-crystal structure ensures that Sacubitril and Valsartan have similar absorption and elimination rates, thereby synchronizing their pharmacological effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in 24-hour ambulatory systolic blood pressure(SBP) | The comparison of the reduction in 24-hour ambulatory systolic blood pressure from baseline between the two groups | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in 24-hour ambulatory diastolic blood pressure(DBP) | The comparison of the reduction in 24-hour ambulatory diastolic blood pressure from baseline between the two groups | From enrollment to the end of treatment at 12 weeks |
| Changes in daytime and nighttime ambulatory blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Tian Chief Physician | Contact | 086-17708130310 | tianwenjie1976@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University |
| UNKNOWN |
| Chengdu First People's Hospital | OTHER |
| Mianyang People's Hospital | UNKNOWN |
| Guan'an People's Hospital | UNKNOWN |
| Meishan Traditional Chinese Medicine Hospital | OTHER |
| Qijiang District People's Hospital | UNKNOWN |
| Meishan People's Hospital | UNKNOWN |
| The First People's Hospital of Guangyuan | UNKNOWN |
| Dazhou Central Hospital | OTHER |
Prospective, Randomized, Controlled, Multicenter Study
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| Valsartan | Drug | Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects. |
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The comparison of the changes in daytime and nighttime ambulatory blood pressure between the two groups. (The mean daytime blood pressure is defined as the average of hourly measurements taken between 6:00 and 22:00, and the mean nighttime is defined as the average of hourly measurements taken between 22:00 and 6:00.) |
| From enrollment to the end of treatment at 12 weeks |
| Rate of dipper blood pressure restoration | The comparison of the proportion of subjects in each group who achieve a dipper blood pressure pattern, defined as a nighttime blood pressure reduction of 10-20% in both systolic and diastolic blood pressure. | From enrollment to the end of treatment at 12 weeks |
| Rate of blood pressure achievement | The comparison of the proportion of subjects in each group who achieve blood pressure targets (SBP < 130 mmHg and DBP < 80 mmHg) | From enrollment to the end of treatment at 12 weeks |
| Rate of hypertension treatment response | The comparison of the proportion of subjects in each group who achieve hypertension treatment response, defined as: SBP < 140 mmHg and/or a reduction from baseline of ≥ 20 mmHg; DBP < 90 mmHg and/or a reduction from baseline of ≥ 10 mmHg; both of them | From enrollment to the end of treatment at 12 weeks |
| Improvement in diabetes condition | Comparison of reductions in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) between the two groups | From enrollment to the end of treatment at 12 weeks |
| Improvement in Renal Function | The comparison of reductions in serum creatinine, urine albumin/creatinine ratio, and blood urea nitrogen between the two groups | From enrollment to the end of treatment at 12 weeks |
| Medication utilization | The comparison of dose escalation proportions and the proportion of subjects requiring adjunctive nifedipine controlled-release tablets between the two groups | From enrollment to the end of treatment at 12 weeks |
| Safety assessments | Safety assessments included monitoring of all adverse events (AEs), serious AEs (SAEs), and regular monitoring of vital signs and clinical laboratory tests. | From enrollment to the end of treatment at 12 weeks |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |