S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement

Sponsor
Hanlim Pharm. Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06130124
Collaborator
(none)
5,000
1
29
172.2

Study Details

Study Description

Brief Summary

Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary purpose:

    Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

    Secondary purpose:
    1. Evaluate the efficacy by comparing the change in blood pressure for each drug pattern (monotherapy or combination therapy) at 6 months after administration of the drug to be studied in patients with essential hypertension.

    2. Evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension.

    3. Evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

    4. Evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement According to 2022 KSH(Korean Society of Hypertension) Guidelines (SHIFT)
    Actual Study Start Date :
    Feb 22, 2023
    Anticipated Primary Completion Date :
    Apr 22, 2025
    Anticipated Study Completion Date :
    Jul 25, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines [after 6 months of prescription for S-Amlodipine compared to baseline]

      The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Adults over 19 years of age

    2. A person who was diagnosed with essential hypertension at the time of participation in the study or was previously diagnosed with essential hypertension and is taking antihypertensive drugs for treatment (Essential hypertension: Systolic blood pressure greater than 140mmHg or diastolic blood pressure greater than 90mmHg)

    3. A person whose prescription for the study drug under study was confirmed at the time of participation in the study

    4. A person who voluntarily decided to participate in this observational study and gave written consent to the consent form

    Exclusion Criteria:
    1. Patients who are contraindicated in administration of study drug according to the permission
    • Patients with a history of hypersensitivity to the study drug or its components or other dihydropyridine-based drugs

    • Women who are pregnant or may be pregnant, and women who are lactating

    • Patients with shock (including cardiogenic shock), severe aortic valve stenosis, unstable angina, within 1 month after myocardial infarction, severe hypotension, severe liver dysfunction

    1. Patients who are inappropriate to participate in the study in the judgement of the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bundang Seoul University Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

    Sponsors and Collaborators

    • Hanlim Pharm. Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanlim Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT06130124
    Other Study ID Numbers:
    • HL-LDN-403
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023