NCT05462535

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,785 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension,Essential

Interventions

Type	Name	Description
DRUG	Amosartan Plus Tab.	Amosartan Plus Tab., Once daily administered per the locally approved product information

Timeline

• Start date: 2018-02-26
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2022-07-18
• Last updated: 2022-07-18

Locations

1 site across 1 country: South Korea