A Phase 4 interventional study of Allisartan Isoproxil and Placebo in Masked Hypertension, sponsored by Yan Li. Completed at 1 site in China. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Yan Li · Phase 4, Interventional, and Prevention
The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.
The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 320 is above the median of 100 across 97 interventional studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →Yan Li is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP\<130/80 mmHg, and daytime BP \<135/85 mmHg, and nighttime BP \<120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil.
Drug: Allisartan Isoproxil
Placebo tablets are identical to the active study drugs, with a similar schedule of administration.
Drug: Placebo
Allisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months.
Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.
Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.
Time frame: 1 year
24h ambulatory blood pressure
Time frame: 1 year
electrocardiogram
calculating Cornell voltage combination and Sokolow-Lyon index
Time frame: 1 year
microalbuminuria/creatinine ratio
Time frame: 1 year
brachial-ankle pulse wave velocity
Time frame: 1 year
incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Oct 2021, 56 months.
Of 14 phase 4 interventional studies under Hypertrophy, Left Ventricular, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 44. This study's 56 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allisartan isoproxil
Hypertrophy, Left Ventricular →
Yan Li