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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nifedipine GITS

Nifedipine GITS 30\~60mg/day

Group Type ACTIVE_COMPARATOR

Nifedipine GITS

Intervention Type DRUG

Nifedipine GITS 30\~60mg/day for 8 weeks

Amlodipine besylate

Amlodipine besylate 5\~10mg/day

Group Type ACTIVE_COMPARATOR

Amlodipine besylate

Intervention Type DRUG

Amlodipine besylate 5\~10mg/day for 8 weeks

Interventions

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Nifedipine GITS

Nifedipine GITS 30\~60mg/day for 8 weeks

Intervention Type DRUG

Amlodipine besylate

Amlodipine besylate 5\~10mg/day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Adalat Norvasc

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No