Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab

Daewoong Pharmaceutical

Status: Completed

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: Olmesartan Medoxomil

Study type: Observational

Funder types: Industry

Identifiers

NCT05184179

DWJ1351_P402

Details and patient eligibility

About

Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).

Full description

The study will start after investigator determines the administration of Olomax tablets based on the investigator's judgement and obtaining informed consent from the subject during subject's daily visit.

The dose of the Olomax tablet for each subject will be determined based on efficacy and drug resistance according to the subject's previous drug administration.

Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).

Efficacy of Olomax tablets will be evaluated based on the data collected from more than 24 weeks to 48 weeks(+8 weeks) from the baseline visit. Safety of Olomax tablets will be evaluated based on the adverse events collected during the study peroid.

Enrollment: 5,450 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults over the age of 19

2. Patients eligible for Olomax Tab. prescription in accordance with the approved product manual in Korea

3. Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators.

   • Antihypertensive agent: Do not include more than 3 agents.
   • Anti-abnormal lipidemia: Do not include more than 2 agents.
   • Subjects who are already administered beta blocker (BB) or diuretics due to other diseases such as angina, not for the purpose of treating hypertension may be included.

4. Consent on the use of information by the patient

Exclusion criteria

1. Patients who have already administered olomax tablets.
2. Subject who fall under ' Do not administer to the following patients' in the precautions for use
3. A patient who does not meet the inclusion/exclusion criteria participates
4. The patient withdraws consent for the study
5. The administration of the study drug is discontinued
6. It is impossible to follow up during the observation period
7. The investigator determines that it is no longer feasible to continue the study