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

NCT02940548 | Terminated Phase 4

• 1 other identifier: 2016PHB013-02
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Nighttime systolic blood pressure reduction

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

  8 weeks

Secondary Outcomes (2)

• The proportion of recovery of dipper rhythm of blood pressure

  8 weeks

• Change of pulse wave velocity

  8 weeks

Other Outcomes (1)

• Incidence of treatment-related adverse events

  8 weeks

Study Arms (2)

Nifedipine GITS

ACTIVE COMPARATOR

Nifedipine GITS 30\~60mg/day

Drug: Nifedipine GITS

Amlodipine besylate

ACTIVE COMPARATOR

Amlodipine besylate 5\~10mg/day

Drug: Amlodipine besylate

Interventions

Nifedipine GITS DRUG

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

Also known as: Adalat

Nifedipine GITS

Amlodipine besylate DRUG

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

Also known as: Norvasc

Amlodipine besylate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jing Liu: lead
• Bayer: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (2)

• 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.

  PMID: 19171788 BACKGROUND

• 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.

  PMID: 32726499 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jing Liu, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 15, 2016
• First Posted: October 21, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)