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

Hanmi Pharmaceutical logo

Hanmi Pharmaceutical

Status

Completed

Conditions

Hypertension
Dyslipidemia

Treatments

Drug: Amosartan Q tablet

Study type

Observational

Funder types

Industry

Identifiers

NCT05450575
HM-AMOQ-OS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,400 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

5,400 participants in 1 patient group

single arm, single group(No interventional)
Description:
Observational
Treatment:
Drug: Amosartan Q tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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