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| Name | Class |
|---|---|
| National Clinical Research Center, Southern Medical University | UNKNOWN |
| Ningbo Yinzhou Community Health Service Center | UNKNOWN |
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Hypertension is a common condition that can cause serious events such as stroke, coronary heart disease and heart failure. Homocysteine (Hcy) is a substance in the body that is harmful to blood vessels. Hyperhomocysteinemia (plasma Hcy≥10 mol/L), which is associated with hypertension, significantly increases the risk of stroke. This type of high blood pressure is called type "H" hypertension. Enalapril folic acid tablet is an innovative drug developed independently in China and is the first choice for the treatment of H type hypertension. Patients with type H hypertension should be treated with enalapril folic acid tablets to reduce stroke.
However, some patients had poor blood pressure control after monotherapy. At this time, other antihypertensive drugs should be used in combination. Amlodipine and Hydrochlorothiazide are the most commonly used and the best combination.
The purpose of this study was to observe the difference in the efficacy of enalapril folic acid tablets in patients with uncontrolled blood pressure who were well tolerated and randomized to aminoclodipine or hydrochlorothiazide in reducing stroke and other cardiovascular and cerebrovascular events, and to explore the relationship between various alternative measures and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enalapril Folic Acid Tablets Combined With amlodipine | Experimental | Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg |
|
| Enalapril Folic Acid Tablets Combined With hydrochlorothiazide | Active Comparator | Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enalapril Folic Acid Tablets Combined With amlodipine | Drug | Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stroke rate | Until 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of combined end points of cardiovascular events | Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction | Until 5 years |
| Rate of all causes of death |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of heart failure (hospitalization) | Until 5 years | |
| Rate of coronary revascularization | Until 5 years | |
| Rate of peripheral arterial revascularization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian-an Wang | Second Affiliated Hospital of Zhejiang University, School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| Enalapril Folic Acid Tablets Combined With hydrochlorothiazide | Drug | Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg |
|
Including all causes and unexplained deaths
| Until 5 years |
| Rate of first or recurrent ischemic stroke | Until 5 years |
| Rate of first or recurrent hemorrhagic stroke | Until 5 years |
| Rate of myocardial infarction | Until 5 years |
| Until 5 years |
| Rate of malignant tumor | Until 5 years |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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