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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.
The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine GITS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine GITS | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Control rate of hypertension evaluated by office blood pressure at 8 weeks | 8 weeks | |
| Control rate of hypertension evaluated by office blood pressure at 4 weeks | 4 weeks | |
| Control rate of hypertension evaluated by office blood pressure at 2 weeks | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks | 8 weeks | |
| Change of office blood pressure from baseline to 8 weeks | 8 weeks | |
| Change of 24-hour ABPM from baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yu, MD | Contact | 8610-83575262 | jiyou_2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Huo, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Peking University First Hospital | Recruiting | Beijing | 100034 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 8 weeks |