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

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT05450575
Collaborator
(none)
5,400
Enrollment
1
Location
39.1
Actual Duration (Months)
138.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia.

During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q 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 Q tablet

Detailed Description

This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.

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 Q 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 :
5400 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia
Actual Study Start Date :
Apr 17, 2018
Actual Primary Completion Date :
Jul 20, 2021
Actual Study Completion Date :
Jul 20, 2021

Arms and Interventions

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

Observational

Drug: Amosartan Q tablet
Amlodipine, Losartan, Rosuvastatin
Other Names:
  • amosartan Q

    		•

    Outcome Measures

    Primary Outcome Measures

    1. percentage(%) of patients who achieved target blood pressure [6 months]

    2. percentage(%) of patients who achieved target LDL-C [6 months]

    Eligibility Criteria

    Criteria

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

    • Patients with hypertension and dyslipidemia

    • Those who have already decided to administer Amosartan Q 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 Q tablet is prohibited

    Contacts and Locations

    Locations

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

    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:
    NCT05450575
    Other Study ID Numbers:
    • HM-AMOQ-OS-01
    First Posted:
    Jul 8, 2022
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hanmi Pharmaceutical Company Limited
    Amosartan
    Hypertension
    Dyslipidemia
    Observational
    Additional relevant MeSH terms:
    Hypertension
    Dyslipidemias

    Study Results

    No Results Posted as of Jul 8, 2022