A Phase 4 interventional study of sacubitril/valsartan and Amlodipine in Hypertension and Left Ventricular Hypertrophy, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
Among 140 studies testing valsartan in Hypertension — none open to participants now, none under way, none of them phase 3. Valsartan · Hypertension.
Among the 140 studies testing valsartan in Hypertension, this one is the 88th largest by planned enrollment of the 139 interventional ones that give a count, is the only one that started in 2021, is one of 67 in phase 4, and was the 137th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →None of the 140 studies testing valsartan in Hypertension is open now.
Valsartan: first FDA approval 1996 (DIOVAN), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →140 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2021.
Median enrollment 198 across the 139 interventional studies. Of the 126 that completed or were terminated, 29 (23%) have results posted.
105 of 140 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
15 studies in Hypertension by Shanghai Jiao Tong University School of Medicine: 6 open now, 7 under way, none of them phase 3. Of 4 finished, 0 (0%) have results posted.
Among the 15 studies in Hypertension by Shanghai Jiao Tong University School of Medicine, this one is the 10th largest by planned enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2021, is one of 9 in phase 4, and was the 8th registered.
Shanghai Jiao Tong University School of Medicine’s Hypertension studies by the year they started, since 2008.
None of the studies under way reaches primary completion within a year.
Among the 140 studies testing valsartan in Hypertension, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Shanghai Jiao Tong University School of Medicine’s 15 in Hypertension:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted.
Drug: sacubitril/valsartan
One pill of amlodipine (5mg tablet) + one pill of matching placebo of sacubitril/valsartan daily. If possible, dosage titration should be conducted.
Drug: Amlodipine
Drug pages: Sacubitril · Valsartan
Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.
Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.
Change in LVGLS after 24 weeks
Change in left ventricular global longitudinal strain (LVGLS) after 24-week treatments. At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).
Time frame: Baseline and 24 weeks
Change in LVGLS after 12 weeks
Change in left ventricular global longitudinal strain (LVGLS) after 12-week treatments. At baseline and 12-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).
Time frame: Baseline and 12 weeks
Changes in LVMI after 24 weeks
At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8\*{1.04\*\[(LVEDD+IVS+LVPW)\^3-LVEDD\^3\]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI).
Time frame: Baseline and 24 weeks
Changes in LVMI after 12 weeks
At baseline and 12-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8\*{1.04\*\[(LVEDD+IVS+LVPW)\^3-LVEDD\^3\]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI).
Time frame: Baseline and 12 weeks
Blood pressure after 24 weeks
Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 24-week treatments.
Time frame: Baseline and 24 weeks
Blood pressure after 12 weeks
Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 12-week treatments.
Time frame: Baseline and 12 weeks
Started Nov 2021 (actual). Primary completion is estimated for Jun 2023, 19 months after the start.
Of 126 non-industry phase 4 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 19 months is below that.
Counting every sponsor, half of 161 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sacubitril · Valsartan
Shanghai Jiao Tong University School of Medicine →