Not yet recruitingNCT06501651Hyper-SaveUpdated Jul 15, 2024

Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy

A Phase 4 interventional study of Sacubitril/Valsartan and Valsartan in Essential Hypertension, Type 2 Diabetes and Nephropathy, sponsored by Sichuan Academy of Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Sichuan Academy of Medical Sciences · Phase 4, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 4
Study type: Interventional
Enrollment: 297
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Essential Hypertension
Type 2 Diabetes
Nephropathy

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Keywords

Essential hypertension
Type 2 diabetes
Nephropathy
Sacubitril/Valsartan

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 297 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Sichuan Academy of Medical Sciences is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 18 years or older, no gender restriction;
Diagnosed with mild to moderate primary hypertension (140 ≤ SBP \< 180 mmHg and/or 90 ≤ DBP \< 110 mmHg), including newly diagnosed or inadequately treated patients (those who have not followed previous medical advice and have uncontrolled blood pressure according to the investigator);
Diagnosed with type 2 diabetes (according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)), and meeting the following conditions: a) Continuously on ≥ 1 glucose control medication regimens (which may include long-acting insulin) for at least 12 weeks before screening, with a stable treatment regimen (i.e., the same medication and dosage) for at least 28 days before screening, and maintaining this regimen during the study. At the investigator's discretion, the dose of supplemental short-acting insulin can be adjusted as needed to achieve adequate glucose control; b) HbA1c level ≤ 10.5% and fasting (≥ 8 hours) plasma glucose level ≤ 13.3 mmol/L (if fasting glucose > 13.3 mmol/L, the investigator may repeat the test to determine eligibility);
Urine albumin/creatinine ratio (UACR) ≥ 30 mg/g in two measurements taken on separate days or eGFR \< 60 mL/min/1.73 m²;
Non-pregnant or fertile patients (male or female) using reliable contraception;
Female patients with potential for pregnancy must have a negative pregnancy test at screening;
Subjects must voluntarily agree to comply strictly with the study protocol requirements and sign a written informed consent form.

Exclusion criteria

Exclusion Criteria:

Presence of severe hypertension, malignant hypertension, hypertensive emergencies, or hypertensive crises;
History or evidence of secondary hypertension within 12 months before screening, including but not limited to any of the following: renovascular hypertension, renal parenchymal hypertension, unilateral or bilateral renal artery stenosis, coarctation of the aorta, primary aldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension;
History of angioedema (drug-related or other causes) within 12 months before screening;
Presence of diabetic ketoacidosis;
History or evidence of secondary diabetes within 12 months before screening, including but not limited to any of the following: endocrine disorders causing carbohydrate metabolism disorders, pancreatogenic diabetes, hepatogenic diabetes, nephrogenic diabetes, etc.;
History of malignancy in any organ system (excluding localized basal cell carcinoma of the skin);
History of acute stroke, lacunar infarction, or dementia within 6 months before screening;
History of coronary artery bypass graft surgery or any percutaneous coronary intervention (PCI) within 6 months before screening;
Previously diagnosed or currently diagnosed heart failure (NYHA Class III-IV) or clinically significant valvular heart disease;
History or current diagnosis of cardiac abnormalities: (1) second or third-degree atrioventricular block without a pacemaker; (2) clinically significant arrhythmias, including atrial fibrillation with a ventricular rate ≥ 120 bpm; (3) family history of long QT syndrome or torsades de pointes ventricular tachycardia;
Chronic kidney disease stage 4 or higher (eGFR \< 30 mL/min/1.73 m²), receiving renal dialysis, or history of kidney transplantation;
Significant abnormalities in laboratory tests, such as potassium levels > 5.5 mmol/L or \< 3.5 mmol/L, sodium levels \< 130 mmol/L, liver function (ALT, AST) results > 3 times the upper limit of normal;
History of allergy to antihypertensive drugs such as ARBs, Angiotensin-Converting Enzyme (ACE) inhibitors, or renin inhibitors;
Clear history of intolerance to drugs similar to the study medication (e.g., ACE inhibitors, ARBs);
Use of traditional Chinese or Western medicines that could affect the study's efficacy during the study period (see appendix for list);
Any surgery or medical condition that significantly alters the absorption, distribution, metabolism, or excretion of any medication, including but not limited to the following: clinically significant gastrointestinal surgery within 12 months before the screening (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastroenterostomy, or gastric banding), current active inflammatory bowel disease or history of active inflammatory bowel disease;
Pregnant or breastfeeding women, or patients of childbearing potential unwilling or unable to use effective contraception during the study period;
Participation in another clinical study using any investigational drug or observational study within 30 days before screening;
Other conditions that, in the investigator's judgment, may affect the conduct of the clinical study or the determination of study results.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 297 participants (estimated)

Study arms

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.
Drug: Sacubitril/Valsartan
Active comparator
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.
Drug: Valsartan

Interventions

DrugSacubitril/Valsartan
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.
DrugValsartan
Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects.

What researchers measure

Primary outcomes

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
Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

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
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in daytime and nighttime ambulatory blood pressure
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.)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks

Study locations

1 site

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072, China
- Hospital Operator · Contact · syyirb@163.com · 086-028-87393401

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06501651
Lead sponsor: Sichuan Academy of Medical Sciences
Collaborators: The Second Affiliated Hospital of Chongqing Medical University, Nanchong Central Hospital, The People's Hospital of Leshan, The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University, Chengdu First People's Hospital, Mianyang People's Hospital, Guan'an People's Hospital, Meishan Traditional Chinese Medicine Hospital, Qijiang District People's Hospital, Meishan People's Hospital, The First People's Hospital of Guangyuan, Dazhou Central Hospital
Responsible party: tianwenjie1976 (Chief Physician, Sichuan Academy of Medical Sciences) — Principal investigator
First posted: Jul 15, 2024
Start date: Aug 1, 2024 (estimated)
Primary completion: Apr 10, 2025 (estimated)
Completion: Apr 10, 2025 (estimated)
Last update: Jul 15, 2024

Study contacts

Wenjie Tian Chief Physician

Contact

tianwenjie1976@hotmail.com

086-17708130310

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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