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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05958524
Other study ID # 2023-49
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date November 1, 2023

Study information

Verified date August 2023
Source The Second Affiliated Hospital of Chongqing Medical University
Contact Xian Yu, professor
Phone 18512356862
Email 1clinicaltrial@hospital.cqmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Preliminarily explore the correlation factors of differences in the efficacy of levamlodipine besylate in the treatment of hypertension. 2. Quantitatively analyze the influence of covariates such as patient demographic factors, personal history, combined medications, and biochemical indicators on the efficacy of levamlodipine besylate, and establish a population pharmacokinetic model of levamlodipine besylate, to achieve clinical Individualized treatment and rational drug use.


Description:

This study is a retrospective study, which intends to collect and extract relevant information from outpatient medical records from the information center of our hospital, and evaluate the difference in the efficacy of antihypertensive treatment with levamlodipine besylate in newly diagnosed hypertensive patients in our hospital; After antihypertensive treatment with levamlodipine besylate, the correlation analysis was carried out on the influencing factors of blood pressure control in the follow-up, and the covariates such as demographic factors, personal history, combined medications, and biochemical indicators were initially explored. The curative effect of dipine. Through the population pharmacokinetic modeling method of quantitative pharmacology, the influence of covariates such as demographic factors, personal history, combined medication, and biochemical indicators on the curative effect of levamlodipine besylate was quantitatively explored. The population pharmacokinetic model of levamlodipine besylate was established in order to provide reference for clinical individualized treatment and rational drug use.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Newly diagnosed patients with hypertension in our hospital (sex, age is not limited). 2. Patients whose initial treatment is levamlodipine besylate. Exclusion Criteria: 1. Patients who cannot be followed up regularly or are lost to follow-up after initial diagnosis and treatment. 2. Patients who were initially treated with other antihypertensive drugs. 3. Blood pressure was not measured when the patient came to the hospital for follow-up.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yu Xian Chongqing

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The systolic blood pressure The systolic blood pressure was measured at rest Patient's follow-up after initial treatment was 1 month
Primary The diastolic blood pressure The diastolic blood pressure was measured at rest Patient's follow-up after initial treatment was 1 month
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