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

July 14, 2022 updated by: Hanmi Pharmaceutical Company Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05545
        • Hanmi Pharmaceutical Company Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Uncontrolled essential hypertension patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in SBP/DBP
Time Frame: 24 weeks
24 weeks
Percentage from baseline in SBP/DBP
Time Frame: 24 weeks
24 weeks
Percentage of patients achieving target blood pressure
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-AMOP-OS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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