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An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT05462535
Collaborator
(none)
4,785
Enrollment
1
Location
40.6
Actual Duration (Months)
117.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.

During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.

In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Condition or Disease Intervention/Treatment Phase
  • Drug: Amosartan Plus Tab.

Detailed Description

This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Study Design

Study Type:
Observational
Actual Enrollment :
4785 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients
Actual Study Start Date :
Feb 26, 2018
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Single arm, Single group(No interventional)

Observational

Drug: Amosartan Plus Tab.
Amosartan Plus Tab., Once daily administered per the locally approved product information
Other Names:
  • Amlodipine camsylate, Losartan potassium, Chlorthalidone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in SBP/DBP [24 weeks]

    2. Percentage from baseline in SBP/DBP [24 weeks]

    3. Percentage of patients achieving target blood pressure [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Uncontrolled essential hypertension patients

    • Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher

    • Those who voluntarily decided to participate in this study and consented in writing to the consent form

    Exclusion Criteria:
    • Patients for whom use of Amosartan Plus tablet is prohibited

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hanmi Pharmaceutical Company Limited Seoul Korea, Republic of 05545

    Sponsors and Collaborators

    • Hanmi Pharmaceutical Company Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanmi Pharmaceutical Company Limited
    ClinicalTrials.gov Identifier:
    NCT05462535
    Other Study ID Numbers:
    • HM-AMOP-OS-01
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Losartan
    Amlodipine
    Chlorthalidone

    Study Results

    No Results Posted as of Jul 18, 2022