NCT02940548

Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Jing Liu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. \-

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Nifedipine GITS	Nifedipine GITS 30\~60mg/day for 8 weeks
DRUG	Amlodipine besylate	Amlodipine besylate 5\~10mg/day for 8 weeks

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-10-21
• Last updated: 2022-04-29

Locations

1 site across 1 country: China