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

September 12, 2023 updated by: The Second Affiliated Hospital of Chongqing Medical University
  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The systolic blood pressure
Time Frame: Patient's follow-up after initial treatment was 1 month
The systolic blood pressure was measured at rest
Patient's follow-up after initial treatment was 1 month
The diastolic blood pressure
Time Frame: Patient's follow-up after initial treatment was 1 month
The diastolic blood pressure was measured at rest
Patient's follow-up after initial treatment was 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Xian Yu, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Monotherapy

Clinical Trials on blood pressure control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe