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

Study Overview
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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.

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

Conditions
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Hypertension,Essential

Intervention / Treatment
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* Drug: Amosartan Plus Tab.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm, Single group(No interventional)<br>Observational | Drug: Amosartan Plus Tab.<br>* Amosartan Plus Tab., Once daily administered per the locally approved product information<br>* Other names: Amlodipine camsylate, Losartan potassium, Chlorthalidone;|

What is the study measuring?
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Primary Outcome Measures

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