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The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Reference Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Sacubitril/Allisartan and Amlodipine Group | Drug | Drug: Sacubitril/Allisartan and Amlodipine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The baseline change in mean seated systolic blood pressure (msSBP) | Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment | at 12 weeks |
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Inclusion Criteria:
Patients 18-75 years old.
Confirmed diagnosis of essential hypertension.
Patients who meet one of the following criteria when screening:
A. Treatment-naive patients (newly diagnosed essential hypertension, or patients with a prior hypertension history who have not taken any antihypertensive medication for at least 4 weeks prior to screening): mean seated systolic blood pressure (msSBP) ≥150 mmHg and <180 mmHg.
B. Patients with irregular oral administration of amlodipine besylate (5 mg once daily) (treatment duration less than 4 weeks before screening, or more than 5 missed dosing days within the 4 weeks prior to screening): msSBP ≥140 mmHg and<180 mmHg.
C. Patients on existing stable antihypertensive therapy (receiving a stable dose of another single-agent antihypertensive, free combination of two single-agent drugs, or single-pill fixed-dose combination containing two active ingredients for at least 4 weeks prior to screening): msSBP ≥140 mmHg and <180 mmHg, and the physician determines that switching treatment to amlodipine besylate (5 mg once daily) is clinically appropriate.
D. Patients with essential hypertension who have been regularly treated with amlodipine besylate (5mg once daily) for ≥4 weeks and have msSBP ≥140 mmHg and<180 mmHg. The previously regularly administered product shall be Norvasc® or generic amlodipine besylate that has passed the generic consistency evaluation in China.
At randomization, subjects must have msSBP ≥140 mmHg and <180 mmHg.
Subjects voluntarily participate in the trial and sign the written informed consent form.
For subjects enrolled for ambulatory blood pressure monitoring (ABPM): in addition to all above inclusion criteria, one further requirement must be satisfied: valid ABPM report with a 24-hour average blood pressure ≥130/80 mmHg. (Subjects failing to meet Criterion 6 remain eligible for the main trial without ABPM testing.)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| Active Comparator: Amlodipine Group | Drug | Drug: Amlodipine |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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