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

NCT ID: NCT05462535

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4785 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-26

Study Completion Date

2021-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension,Essential

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm, Single group(No interventional)

Observational

Amosartan Plus Tab.

Intervention Type DRUG

Amosartan Plus Tab., Once daily administered per the locally approved product information

Interventions

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Amosartan Plus Tab.

Amosartan Plus Tab., Once daily administered per the locally approved product information

Intervention Type DRUG

Other Intervention Names

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Amlodipine camsylate, Losartan potassium, Chlorthalidone

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanmi Pharmaceutical Company Limited

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-AMOP-OS-01

Identifier Type: -

Identifier Source: org_study_id

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