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

Completed

• Conditions: Hypertension,Essential
• Interventions: Drug: Amosartan Plus Tab.

• Registration Number: NCT05462535
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2018-02-26
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4785

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm, Single group(No interventional)	Amosartan Plus Tab.	Observational

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company Limited; 🇰🇷 Seoul, Korea, Republic of