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NCT05450575 Clinical Trial

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

Hypertension Clinical Trial

Official title:
A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05450575
Other study ID # HM-AMOQ-OS-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2018
Est. completion date July 20, 2021

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

Clinical Trial Summary

This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia. During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q 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 multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia. 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 Q tablet. This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Recruitment information / eligibility
Status Completed
Enrollment 5400
Est. completion date July 20, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients with hypertension and dyslipidemia - Those who have already decided to administer Amosartan Q 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 Q tablet is prohibited

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amosartan Q tablet
Amlodipine, Losartan, Rosuvastatin

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 percentage(%) of patients who achieved target blood pressure 6 months
Primary percentage(%) of patients who achieved target LDL-C 6 months
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