Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling

Recruiting

• Conditions: Hypertensive Patients; Monotherapy

• Registration Number: NCT05958524
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The systolic blood pressure	Patient's follow-up after initial treatment was 1 month	The systolic blood pressure was measured at rest
The diastolic blood pressure	Patient's follow-up after initial treatment was 1 month	The diastolic blood pressure was measured at rest

Trial Locations

Locations (1)

Yu Xian; 🇨🇳 Chongqing, China