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

April 23, 2022 updated by: Jing Liu

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nifedipine GITS
Nifedipine GITS 30~60mg/day
Drug: Nifedipine GITS
Nifedipine GITS 30~60mg/day for 8 weeks
Other Names:
  • Adalat
Active Comparator: Amlodipine besylate
Amlodipine besylate 5~10mg/day
Drug: Amlodipine besylate
Amlodipine besylate 5~10mg/day for 8 weeks
Other Names:
  • Norvasc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nighttime systolic blood pressure reduction
Time Frame: 8 weeks
Compare the effects of two active drugs on nighttime systolic blood pressure reduction
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Liu

Collaborators

Bayer

Investigators

  • Principal Investigator: Jing Liu, M.D., Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016PHB013-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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