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NCT Number: NCT05462535

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

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amosartan Plus Tab.

Drug

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

Other names: Amlodipine camsylate, Losartan potassium, Chlorthalidone

Primary outcomes

  1. Change from baseline in SBP/DBP

    Time frame: 24 weeks

  2. Percentage from baseline in SBP/DBP

    Time frame: 24 weeks

  3. Percentage of patients achieving target blood pressure

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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