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

Hanmi Pharmaceutical logo

Hanmi Pharmaceutical

Status

Completed

Conditions

Hypertension,Essential

Treatments

Drug: Amosartan Plus Tab.

Study type

Observational

Funder types

Industry

Identifiers

NCT05462535
HM-AMOP-OS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,785 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

4,785 participants in 1 patient group

Single arm, Single group(No interventional)
Description:
Observational
Treatment:
Drug: Amosartan Plus Tab.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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