Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness (NARRAS)
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|ClinicalTrials.gov Identifier: NCT02940548|
Recruitment Status : Unknown
Verified December 2016 by Jing Liu, Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : October 21, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Nifedipine GITS Drug: Amlodipine besylate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Nifedipine GITS
Nifedipine GITS 30~60mg/day
Drug: Nifedipine GITS
Nifedipine GITS 30~60mg/day for 8 weeks
Other Name: Adalat
Active Comparator: Amlodipine besylate
Amlodipine besylate 5~10mg/day
Drug: Amlodipine besylate
Amlodipine besylate 5~10mg/day for 8 weeks
Other Name: Norvasc
- Nighttime systolic blood pressure reduction [ Time Frame: 8 weeks ]Compare the effects of two active drugs on nighttime systolic blood pressure reduction
- The proportion of recovery of dipper rhythm of blood pressure [ Time Frame: 8 weeks ]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.
- Change of pulse wave velocity [ Time Frame: 8 weeks ]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.
- Incidence of treatment-related adverse events [ Time Frame: 8 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940548
|Contact: Jing Liu, M.D.||firstname.lastname@example.org|
|Peking University People's Hospital||Recruiting|
|Beijing, China, 100044|
|Contact: Jing Liu, M.D. 861088325457 email@example.com|
|Principal Investigator: Jing Liu, M.D.|
|Principal Investigator:||Jing Liu, M.D.||Peking University People's Hospital|