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

Monotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958524
• Other study ID #: 2023-49
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hypertensive Patients
• Monotherapy

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