Essential HypertensionPhase 4Hyper-SaveNCT06501651
Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy
A Phase 4 study testing Sacubitril/Valsartan and Valsartan in people with Essential Hypertension and Type 2 Diabetes, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension, Type 2 Diabetes, Nephropathy
- What is being tested?
- Sacubitril/Valsartan and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 10 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Hospital Operator, 086-028-87393401, syyirb@163.com
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Study of Sacubitril/Valsartan in the Treatment of Patients With Mild to Moderate Essential Hypertension and Type 2 Diabetic Nephropathy: The Hyper-Save Study
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
- Essential Hypertension, Type 2 Diabetes, Nephropathy
- Being tested
- Sacubitril/Valsartan, Valsartan
- Keywords
- Essential hypertension, Type 2 diabetes, Nephropathy, Sacubitril/Valsartan
- Medical subject headings
- Essential Hypertension, Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/ValsartanDrug
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.
ValsartanDrug
Valsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sacubitril/Valsartan |
| 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. Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
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
Measured: 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.)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- Model description
- Prospective, Randomized, Controlled, Multicenter Study
- Masking
- None (open label)
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- 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, Guang'an people's hospital of Sichuan province, 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
- Principal investigator, tianwenjie1976, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501651
- Sponsor's protocol ID
- Ethical Review 2024(15-1)
- Acronym
- Hyper-Save
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 15 Jul 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Study of Sacubitril/Valsartan in the Treatment of Patients With Mild to Moderate Essential Hypertension and Type 2 Diabetic Nephropathy: The Hyper-Save Study
- ClinicalTrials.gov ID
- NCT06501651
- Acronym / sponsor ID
- Hyper-Save / Ethical Review 2024(15-1)
- Conditions
- Essential Hypertension, Type 2 Diabetes, Nephropathy
- Keywords
- Essential hypertension, Type 2 diabetes, Nephropathy, Sacubitril/Valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- 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, Guang'an people's hospital of Sichuan province, Meishan Traditional Chinese Medicine Hospital, Qijiang District People's Hospital, Meishan People's Hospital, The First People's Hospital of Guangyuan, Dazhou Central Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 15 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Controlled, Multicenter Study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Sacubitril/ValsartanInitial 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. |
| Comparator | Active comparator | Drug: ValsartanInitial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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.;
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 |
|---|---|---|
| Sacubitril/ValsartanSacubitril/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. | Drug | Experimental |
| ValsartanValsartan, effectively inhibits the Ang II type 1 receptor (AT1R), providing both antihypertensive and organ-protective effects. | Drug | Comparator |
Primary outcome
Reduction in 24-hour ambulatory systolic blood pressure(SBP)
Time frame: From enrollment to the end of treatment at 12 weeks
The comparison of the reduction in 24-hour ambulatory systolic blood pressure from baseline between the two groups
9 secondary outcomes
Reduction in 24-hour ambulatory diastolic blood pressure(DBP)
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in daytime and nighttime ambulatory blood pressure
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of dipper blood pressure restoration
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of blood pressure achievement
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of hypertension treatment response
Time frame: From enrollment to the end of treatment at 12 weeks
Improvement in diabetes condition
Time frame: From enrollment to the end of treatment at 12 weeks
Improvement in Renal Function
Time frame: From enrollment to the end of treatment at 12 weeks
Medication utilization
Time frame: From enrollment to the end of treatment at 12 weeks
Safety assessments
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
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 Sacubitril/Valsartan and Valsartan in people with Essential Hypertension and Type 2 Diabetes, run by Sichuan Academy of Medical Sciences 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 19 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: status not confirmed, as of the sponsor's last update on 15 Jul 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Tian Chief Physician (086-17708130310, tianwenjie1976@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in 24-hour ambulatory systolic blood pressure(SBP) (time frame: From enrollment to the end of treatment at 12 weeks). 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 15 Jul 2024.