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

NCT ID: NCT05184179

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-08-16

Brief Summary

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).

Detailed 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.

Conditions

Hypertension; Dyslipidemia

Study Design

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

Interventions

Olmesartan Medoxomil

Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca

Intervention Type: DRUG

Other Intervention Names

Amoldipine Besylate; Rosuvastatin Ca

Eligibility Criteria

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

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

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

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

DWJ1351_P402

Identifier Type: -

Identifier Source: org_study_id