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

A Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia

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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemia
• Intervention / Treatment: Drug: Olmesartan Medoxomil

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.

• Study Type: Observational
• Enrollment (Actual): 5450

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Hwaseong-si, Gyeonggi, Korea, Republic of, 18450
      • Hallym University Dongtan Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The number of patients was calculated based on the analysis results of the blood pressure treatment goal achievement rate and LDL-C treatment goal acheivement rate in the Olomax Tertiary Clinical Trial.

n=(〖Z_(α/2)〗^2×p(1-p))/d^2

:: Type 1 error (=0.05) p: Target Reach Rate at 24+ Weeks (=80%) d: Sampling error

herefore, it means that the total number of patients required to be 95% confident that the proportion of patients whose two primary evaluation variables, blood pressure and LDL, will be included in 79-81%. Considering the dropout rate of about 20%, a total of 7,684 patients are required, so in this study, approximately 8,000 patients approximating this are finally recruited.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure treatment goal achievement rate	Blood pressure treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose blood pressure reached the target value	more than 24 weeks
LDL-C treatment goal achievement rate	LDL-C treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose LDL-C reached the target level	more than 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Change in blood pressure at 24 to 48 weeks compared to baseline	24 to 48 weeks
The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal	The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal at 24 to 48 weeks	24 to 48 weeks
the percentage of patients maintaining the treatment goal and the amount of change in blood pressure	Among patients who reached the treatment goal at baseline, the percentage of patients maintaining the treatment goal and the amount of change in blood pressure at 24 to 48 weeks for each antihypertensive drug (single, double drug combination classification)	24 to 48 weeks
Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal	Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal at 24 to 48 weeks	24 to 48 weeks
For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal	For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal at 24 to 48 weeks by antihypertensive drug (single, combined classification)	24 to 48 weeks
Change in LDL-C	Change in LDL-C at 24 to 48 weeks compared to baseline	24 to 48 weeks
Among patients who reached the treatment goal at baseline, the change in LDL-C, the proportion of patients maintaining the treatment goal	Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks and the proportion of patients maintaining the treatment goal	24 to 48 weeks
Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal	Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks for each anti-dyslipidemia agent and the proportion of eligible patients maintaining the treatment goal	24 to 48 weeks
For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal	For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks	24 to 48 weeks
For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal	For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks for each anti-dyslipidemia agent	24 to 48 weeks
Change amount and rate of change in lipid variables	Change amount and rate of change in lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks compared to the baseline	24 to 48 weeks
the rate and amount of change in both blood pressure and LDL-C	Patients who underwent FU for more than 24 weeks compared to the baseline, the rate and amount of change in both blood pressure and LDL-C reached the target values	more than 24 weeks
Change in Framingham Risk Score (FRS)	Change in Framingham Risk Score (FRS) over 24 weeks compared to baseline	more than 24 weeks
change in carotid intima-media thickening (CIMT) value	If data exists, change in carotid intima-media thickening (CIMT) value over 24 weeks compared to baseline	more than 24 weeks
hsCRP change	If information is collected, hsCRP change over 24 weeks compared to baseline	more than 24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: DWJ1351_P402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No