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The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat)in the treatment of mild to moderate essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nifedipine CR tablets (Xin Ran) | Experimental | Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period. |
|
| nifedipine CR tablets (Adalat) | Active Comparator | Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nifedipine CR tablets (Xin Ran) | Drug |
| ||
| nifedipine CR tablets (Adalat) |
| Measure | Description | Time Frame |
|---|---|---|
| change in morning blood pressure surge from baseline | 12 weeks | |
| change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in morning blood pressure from baseline | 12 weeks | |
| T/P ratio | 12 weeks | |
| average reduction in systolic blood pressure from 18 to 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| clinical laboratory test and adverse event | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pingjin Gao | Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School | Shanghai | Shanghai Municipality | 200025 | China |
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| Drug |
|
| 12 weeks |
| average reduction in diastolic blood pressure from 18 to 24 hours after administration | 12 weeks |
| smoothness index | 12 weeks |
| change in morning blood pressure surge from baseline | 8 weeks |
| change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline | 8 weeks |
| change in morning blood pressure from baseline | 8 weeks |
| T/P ratio | 8 weeks |
| average reduction in systolic blood pressure from 18 to 24 hours after administration | 8 weeks |
| average reduction in diastolic blood pressure from 18 to 24 hours after administration | 8 weeks |
| smoothness index | 8 weeks |
| change in systolic blood pressure (SBP) from baseline | 12 weeks |
| change in diastolic blood pressure (DBP) from baseline | 12 weeks |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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