A Phase 4 interventional study of Amlodipine 5mg and Losartan in Aortic Stenosis, Aortic Regurgitation and Hypertension, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Hanmi Pharmaceutical Company Limited · Phase 4, Interventional, and Treatment
Among 24 studies in Aortic Valve Stenosis with a site in Korea, Republic of — 6 open to participants now, 10 under way, none of them phase 3. Aortic Valve Stenosis · Korea, Republic of.
Among the 24 studies in Aortic Valve Stenosis with a site in Korea, Republic of, this one is the 8th largest by enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2018, is one of 8 in phase 4, and was the 13th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's enrollment of 128 is close to the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →6 of the 24 studies in Aortic Valve Stenosis with a site in Korea, Republic of are open now, in 1 country. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 19 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2018.
Median enrollment 143 across the 12 interventional studies, 900 across the 12 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
1 of 24 have an industry lead sponsor. The 10 most frequent:
Hanmi Pharmaceutical Company Limited is the lead sponsor of 190 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Hanmi Pharmaceutical Company Limited has 1 study filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Aortic Valve Stenosis with a site in Korea, Republic of, from their registry updates:
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
1.Primary objectives
2.Secondary objectives
To evaluate a rate of disease progression
To evaluate a cumulative incidence rate for each visit time point
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intensive care group is targeted at ≤ 130 mmHg of systolic blood pressure, and treatment is done by changing the current treatment to the investigational product. In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -\> Losartan and Amlodipine 5/50 mg -\> Losartan and Amlodipine 5/100 mg -\> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition.
Drug: Amlodipine 5mg · Drug: Losartan · Drug: Losartan and Amlodipine · Drug: Amlodipine/Losartan/Chlorthalidone
The usual care group is targeted at ≤ 140 mmHg of systolic blood pressure, and treatment is done by maintaining the current treatment, adding the investigational product, or changing the current treatment to the investigational product. In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -\> Losartan and Amlodipine 5/50 mg -\> Losartan and Amlodipine 5/100 mg -\> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition.
Drug: Amlodipine 5mg · Drug: Losartan · Drug: Losartan and Amlodipine · Drug: Amlodipine/Losartan/Chlorthalidone · Drug: current treatment
Amlodipine 5 mg
Also known as: Amodipin Tab.
Losartan Potassium 50 mg
Also known as: Osartan Tab. 50 mg
Drug pages: Losartan · Amlodipine
Amlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg
Also known as: Amosartan Tab. 5/50 mg, Amosartan Tab. 5/100 mg
Drug pages: Amlodipine · Losartan · Chlorthalidone
Amlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg
Also known as: Amosartan Plus Tab. 5/100/12.5 mg
treatment is done by maintaining the current treatment
To evaluate changes from baseline in Left Ventricular Mass at 24M
To evaluate changes from baseline in Left Ventricular Mass at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Time frame: 24 months
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular volumes at 24M
Changes from baseline in Left Ventricular volumes at 24M
Time frame: 24 months
Rate of disease progression
* In case of Aortic Stenosis, to evaluate changes from baseline in Aortic Valve Area, tricuspid regurgitation velocity, Mean Pressure Gradient and Valvulo-arterial impedance at 24M * In case of Aortic Regurgitation, to evaluate changes from baseline in Vena contracta at 24M
Time frame: 24 months
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
Time frame: 6 months, 12 months, 18 months, 24 months
Cumulative incidence rate for each visit time point
Cumulative incidence rate for each visit time point - Death, Cardiovascular death, Heart Failure, Myocardial Infarction, Hospitalization, Aortic Valve Replacement
Time frame: 6 months, 12 months, 18 months, 24 months
Changes from baseline in stroke volume index at 24M
Changes from baseline in stroke volume index at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular ejection fraction at 24M
Changes from baseline in Left Ventricular ejection fraction at 24M
Time frame: 24 months
Occurrence and frequency of adverse events
Occurrence and frequency of adverse events
Time frame: 6 months, 12 months, 18 months, 24 months
Plan to share: Undecided — De-identified individual participant data
Ran from Oct 2018 to primary completion in Jul 2022, 45 months.
Of 24 phase 4 interventional studies under Aortic Valve Stenosis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 45 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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