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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04740840
Other study ID # AHNorthSichuanMC
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 1, 2010
Est. completion date May 2, 2015

Study information

Verified date February 2021
Source Af?liated Hospital of North Sichuan Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension


Description:

A total of 200 inpatients or outpatients in the Department of cardiovascular medicine of the third people's Hospital of Mianyang City from April 2021 to October 2021, who met the diagnostic criteria of ish2020 international hypertension practice guidelines, were selected and randomly divided into control group and experimental group, with 100 cases in each group. The control group was treated with amlodipine and the experimental group was treated with levoamlodipine. The changes of blood pressure and serum inflammatory factors were observed before and after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2, 2015
Est. primary completion date April 2, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ? In line with the diagnostic criteria of ISH2020 International Guidelines for Practice of Hypertension ? Age >18 years old, gender is not limited, during the treatment did not take other drugs that will affect blood pressure: such as antidepressants, oral contraceptives, Chinese herbal medicine, etc.; Voluntary participation and signing of informed consent, and can complete all the visit plan. Exclusion Criteria: - (1) Those who do not want to take blood tests; (2) Left ventricular ejection fraction < 50%, heart rate <50 beats/min; ? Acute coronary syndrome (unstable angina pectoris and myocardial infarction); ? valvular heart disease, congenital heart disease, etc.; Other infectious diseases and malignant tumors; ? Bronchial asthma; ? Abnormal liver function and renal dysfunction (ALT BBB 0 80U/L, CR BBB 1 442mmol/L); Autoimmune diseases or any serious and fatal diseases; ? Receiving lipid-lowering therapy and oral vitamins or antioxidants; They are mentally ill, have no self-awareness, and are unable to express themselves or cooperate with others.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levamlodipine
According to the inclusion criteria of the trial, those who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was treated with 2.5mg levamlodipine to lower blood pressure. Abdominal blood was emptying before the start of the trial and at the first and third month of medication.Data on CRP, TNF-a, IL-6, Lp-PLA2 and ATP were collected.
Amlodipine
According to the inclusion criteria, patients who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was given 5mg amlodipine to lower blood pressure. Fasting blood was collected before the trial and during the first and third months of treatment. CRP, TNF-a, IL-6, Lp-PLA2 and ATP data were collected.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Af?liated Hospital of North Sichuan Medical College First Hospitals affiliated to the China PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group One month after treatment
Primary the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group One month after treatment
Primary Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs One month after treatment
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