Clinical trial NCT05958524: Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling
Official title: Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertensive Patients
Monotherapy
Keywords: levamlodipine besylate；monotherapy；
Population pharmacodynamics
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed hypertension who were treated with levamlodipine besylate tablets.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The systolic blood pressure
timeFrame: Patient's follow-up after initial treatment was 1 month
measure: The diastolic blood pressure
timeFrame: Patient's follow-up after initial treatment was 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Yu Xian
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Xian Yu
role: PRINCIPAL_INVESTIGATOR
References: