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

Last updated: June 27, 2024
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Completed

Phase

N/A

Condition

Dyslipidemia

Williams Syndrome

Stress

Treatment

Olmesartan Medoxomil

Clinical Study ID

NCT05184179
DWJ1351_P402
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults over the age of 19

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

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

  • 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 toother diseases such as angina, not for the purpose of treating hypertension maybe included.

  1. Consent on the use of information by the patient

Exclusion

Exclusion Criteria:

  1. Patients who have already administered olomax tablets.

  2. Subject who fall under ' Do not administer to the following patients' in theprecautions 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

Study Design

Total Participants: 5450
Treatment Group(s): 1
Primary Treatment: Olmesartan Medoxomil
Phase:
Study Start date:
December 01, 2019
Estimated Completion Date:
August 16, 2022

Study 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.

Connect with a study center

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi 18450
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.