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

Jing Liu

Status and phase

Terminated

Phase 4

Conditions

Hypertension

Treatments

Drug: Nifedipine GITS

Drug: Amlodipine besylate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02940548

2016PHB013-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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