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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05462535

Enrollment

4785

Registered

2022-07-18

Start date

2018-02-26

Completion date

2021-07-15

Last updated

2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

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.

Interventions

DRUGAmosartan Plus Tab.

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026