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The patient recruitment and follow-ups were influenced with the pandemic of COVID-19
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. While the other half participants will take amlodipine besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure monitoring and arterial stiffness examination will be performed before and after pharmaceutical intervention.
Written informed consent will obtained from all the participants. All the adverse reaction or adverse event, related or unrelated to the study drug, will be recorded in detail, including the occurrence time, symptoms and vital signs, degree, duration, laboratory test indexes, treatment methods and results, process, follow-up time, etc.
If serious adverse event occurs, study drugs should be stopped and necessary remedy should be delivered immediately. At the same time, the investigator must report it to the local drug supervision, medical ethics committee and China Food and Drug Administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine GITS | Active Comparator | Nifedipine GITS 30~60mg/day |
|
| Amlodipine besylate | Active Comparator | Amlodipine besylate 5~10mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine GITS | Drug | Nifedipine GITS 30~60mg/day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nighttime systolic blood pressure reduction | Compare the effects of two active drugs on nighttime systolic blood pressure reduction | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of recovery of dipper rhythm of blood pressure | Compare the effects of two active drugs and different time administration on recovery of dipper rhythm. The proportion of blood pressure dipper rhythm at 8 weeks after two drugs administration will be calculated. The proportion of dipper rhythm at 8 weeks after two drugs administration in the morning or at night will also be calculated. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | change of heart rate; change of liver and kidney function; other adverse reactions, such as edema, flushing, etc during 8 weeks of intervention and follow-ups | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Liu, M.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19171788 | Background | de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26. | |
| 32726499 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2022 | |
| Reset | Mar 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2022 | Mar 16, 2023 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Amlodipine besylate | Drug | Amlodipine besylate 5~10mg/day for 8 weeks |
|
|
| 8 weeks |
| Change of pulse wave velocity | Compare the effects of two active drugs on pulse wave velocity(PWV). PWV will be measured before and after 8 weeks two active drugs administration. | 8 weeks |
| Derived |
| Liu J. A comparative study for the effects of nifedipine GITS and amlodipine besylate administrated in daytime or at nighttime on recovery of blood pressure rhythm and arterial stiffness in the young and middle-aged subjects with non-dipper hypertension (NARRAS): Design and rationale. Int J Clin Pract. 2020 Dec;74(12):e13628. doi: 10.1111/ijcp.13628. Epub 2020 Sep 3. |