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

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462535
• Other study ID #: HM-AMOP-OS-01
• Status: Completed
• Start date: February 26, 2018
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4785
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Pharmaceutical Company Limited	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in SBP/DBP		24 weeks
Primary	Percentage from baseline in SBP/DBP		24 weeks
Primary	Percentage of patients achieving target blood pressure		24 weeks