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

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Drug: Nifedipine GITS; Drug: Amlodipine besylate

• Registration Number: NCT02940548
• Lead Sponsor: Jing Liu

Brief 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.

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Study Timeline

• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2016-12
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-23
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Mild to moderate (Office blood pressure : 140 mmHg =< systolic blood pressure (SBP) <180 mmHg and / or 90 mmHg =< diastolic blood pressure (DBP) <110 mmHg) , non-dipper (ambulatory blood pressure monitoring (ABPM): night-time mean SBP / day-time mean SBP >=0.9 and night-time mean SBP >=120 mmHg) hypertensive subjects, who is drug treatment-naive or previously treated but discontinued for 2 weeks or more
• The subject is voluntary to participate in the study and has signed the informed consent form

Exclusion Criteria

• Known allergy to any component of Nifedipine and Amlodipine
• Office SBP >=180 mmHg and / or DBP >=110 mmHg in the screening period
• The patient who is taking calcium antagonists (monotherapy or combination with other drugs)
• Evidences of secondary hypertension
• History of cerebrovascular events, cardiac failure, serious coronary artery disease within 12 months
• Type 1 diabetes mellitus (DM)
• Severe liver diseases or renal insufficiency
• The pregnant woman, the woman who may be pregnant or plan to be pregnant, or the lactating woman
• The subject who needs to work at night (on night shift)
• Other reasons that the subject can not participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine GITS	Nifedipine GITS	Nifedipine GITS 30\~60mg/day
Amlodipine besylate	Amlodipine besylate	Amlodipine besylate 5\~10mg/day

Primary Outcome Measures

Name	Time	Method
Nighttime systolic blood pressure reduction	8 weeks	Compare the effects of two active drugs on nighttime systolic blood pressure reduction

Secondary Outcome Measures

Name	Time	Method
The proportion of recovery of dipper rhythm of blood pressure	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	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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China