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

NCT05958524 | Unknown

• 1 other identifier: 2023-49
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Preliminarily explore the correlation factors of differences in the efficacy of levamlodipine besylate in the treatment of hypertension.
2. 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.

Conditions

Hypertensive Patients; Monotherapy

Keywords

levamlodipine besylate；monotherapy；; Population pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• The systolic blood pressure

  The systolic blood pressure was measured at rest

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

• The diastolic blood pressure

  The diastolic blood pressure was measured at rest

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Newly diagnosed patients with hypertension in our hospital (sex, age is not limited).
• Patients whose initial treatment is levamlodipine besylate.

You may not qualify if:

• Patients who cannot be followed up regularly or are lost to follow-up after initial diagnosis and treatment.
• Patients who were initially treated with other antihypertensive drugs.
• Blood pressure was not measured when the patient came to the hospital for follow-up.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Yu Xian

Chongqing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Xian Yu

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian Yu, professor

CONTACT

18512356862; 1clinicaltrial@hospital.cqmu.edu.cn

Guoxing L

CONTACT

18875213526; 2315714374@qq.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 24, 2023
• Study Start: December 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)