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

NCT ID: NCT05450575

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2021-07-20

Brief 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.

Detailed 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.

Conditions

Hypertension; Dyslipidemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

single arm, single group(No interventional)

Observational

Amosartan Q tablet

Intervention Type: DRUG

Amlodipine, Losartan, Rosuvastatin

Interventions

Amosartan Q tablet

Amlodipine, Losartan, Rosuvastatin

Intervention Type: DRUG

Other Intervention Names

amosartan Q

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hanmi Pharmaceutical Company Limited

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-AMOQ-OS-01

Identifier Type: -

Identifier Source: org_study_id