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RecruitingNCT05958524Updated Sep 14, 2023

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

An observational study in Hypertensive Patients and Monotherapy, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 9 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Hypertensive Patients
  • Monotherapy

Keywords

  • levamlodipine besylate;monotherapy;
  • Population pharmacodynamics
03

In context

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 98 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed hypertension who were treated with levamlodipine besylate tablets.

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

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The systolic blood pressure

    The systolic blood pressure was measured at rest

    Time frame: Patient's follow-up after initial treatment was 1 month

  2. The diastolic blood pressure

    The diastolic blood pressure was measured at rest

    Time frame: Patient's follow-up after initial treatment was 1 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05958524
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Responsible party
Sponsor
First posted
Jul 24, 2023
Start date
Dec 15, 2022
Primary completion
Nov 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Sep 14, 2023

Study contacts

Xian Yu, professor
Contact
1clinicaltrial@hospital.cqmu.edu.cn
18512356862
Guoxing L
Contact
2315714374@qq.com
18875213526
Xian Yu
principal investigator · The Second Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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