Back to results

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

Primary Purpose

Hypertension

Status

Terminated

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Nifedipine GITS

Amlodipine besylate

About this trial

This is an interventional treatment trial for Hypertension focused on measuring non-dipper hypertension, young, middle-aged, ambulatory blood pressure monitoring, arterial stiffness, nifedipine gastrointestinal therapeutic system (GITS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Nifedipine GITS

Amlodipine besylate

Arm Description

Nifedipine GITS 30~60mg/day

Amlodipine besylate 5~10mg/day

Outcomes

Primary Outcome Measures

Nighttime systolic blood pressure reduction

Compare the effects of two active drugs on nighttime systolic blood pressure reduction

Secondary Outcome Measures

The proportion of recovery of dipper rhythm of blood pressure

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

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.

Full Information

NCT ID

NCT02940548

First Posted

October 15, 2016

Last Updated

April 23, 2022

Sponsor

Jing Liu

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02940548

Brief Title

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

Acronym

NARRAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

The patient recruitment and follow-ups were influenced with the pandemic of COVID-19

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jing Liu

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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. -

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

non-dipper hypertension, young, middle-aged, ambulatory blood pressure monitoring, arterial stiffness, nifedipine gastrointestinal therapeutic system (GITS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nifedipine GITS

Arm Type

Active Comparator

Arm Description

Nifedipine GITS 30~60mg/day

Arm Title

Amlodipine besylate

Arm Type

Active Comparator

Arm Description

Amlodipine besylate 5~10mg/day

Intervention Type

Drug

Intervention Name(s)

Nifedipine GITS

Other Intervention Name(s)

Adalat

Intervention Description

Nifedipine GITS 30~60mg/day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Amlodipine besylate

Other Intervention Name(s)

Norvasc

Intervention Description

Amlodipine besylate 5~10mg/day for 8 weeks

Primary Outcome Measure Information:

Title

Nighttime systolic blood pressure reduction

Description

Compare the effects of two active drugs on nighttime systolic blood pressure reduction

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

The proportion of recovery of dipper rhythm of blood pressure

Description

Time Frame

8 weeks

Title

Change of pulse wave velocity

Description

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.

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Incidence of treatment-related adverse events

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Liu, M.D.

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Beijing

ZIP/Postal Code

100044

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

19171788

Citation

de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.

Results Reference

background

PubMed Identifier

32726499

Citation

Liu J. A comparative study for the effects of nifedipine GITS and amlodipine besylate administrated in daytime or at nighttime on recovery of blood pressure rhythm and arterial stiffness in the young and middle-aged subjects with non-dipper hypertension (NARRAS): Design and rationale. Int J Clin Pract. 2020 Dec;74(12):e13628. doi: 10.1111/ijcp.13628. Epub 2020 Sep 3.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs