Hypertensive PatientsNCT05958524
Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling
An observational study of Hypertensive Patients and Monotherapy, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertensive Patients, Monotherapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed hypertension who were treated with levamlodipine besylate tablets.
Who may be able to join
- Newly diagnosed patients with hypertension in our hospital (sex, age is not limited).
- Patients whose initial treatment is levamlodipine besylate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu Xian
Chongqing
Xian Yu, Professor, 18512356862, 1clinicaltrial@hospital.cqmu.edu.cn
Guoxing L, 18875213526, 2315714374@qq.com
About this study
- Preliminarily explore the correlation factors of differences in the efficacy of levamlodipine besylate in the treatment of hypertension.
- 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.
- Conditions
- Hypertensive Patients, Monotherapy
- Keywords
- levamlodipine besylate；monotherapy；, Population pharmacodynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
The systolic blood pressure
The systolic blood pressure was measured at rest
Measured: Patient's follow-up after initial treatment was 1 month
The diastolic blood pressure
The diastolic blood pressure was measured at rest
Measured: Patient's follow-up after initial treatment was 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Dec 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xian Yu, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958524
- Sponsor's protocol ID
- 2023-49
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling
- ClinicalTrials.gov ID
- NCT05958524
- Acronym / sponsor ID
- 2023-49
- Conditions
- Hypertensive Patients, Monotherapy
- Keywords
- levamlodipine besylate；monotherapy；, Population pharmacodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Preliminarily explore the correlation factors of differences in the efficacy of levamlodipine besylate in the treatment of hypertension.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed hypertension who were treated with levamlodipine besylate tablets.
Key inclusion criteria (2 listed)
- Newly diagnosed patients with hypertension in our hospital (sex, age is not limited).
- Patients whose initial treatment is levamlodipine besylate.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The systolic blood pressure
Time frame: Patient's follow-up after initial treatment was 1 month
The systolic blood pressure was measured at rest
The diastolic blood pressure
Time frame: Patient's follow-up after initial treatment was 1 month
The diastolic blood pressure was measured at rest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian Yu principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Patients and Monotherapy, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian Yu, professor (18512356862, 1clinicaltrial@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The systolic blood pressure (time frame: Patient's follow-up after initial treatment was 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.