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

Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02940548
• Other study ID #: 2016PHB013-02
• Status: Terminated
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nifedipine GITS
Nifedipine GITS 30~60mg/day for 8 weeks
• Amlodipine besylate
Amlodipine besylate 5~10mg/day for 8 weeks

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jing Liu	Bayer

Country where clinical trial is conducted

China, 

References & Publications (1)

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, Pallarés V, Sarría 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-related adverse events	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
Primary	Nighttime systolic blood pressure reduction	Compare the effects of two active drugs on nighttime systolic blood pressure reduction	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks