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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05184179
• Other study ID #: DWJ1351_P402
• Status: Enrolling by invitation
• Start date: December 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7000
• Est. completion date: March 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Olmesartan Medoxomil
Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure treatment target achievement rate	Evaluation of blood pressure treatment target achievement rate against baseline	After more than 24 weeks of Olomax Tab. administration to 48 weeks(+8 weeks)
Primary	LDL-C treatment target achievement rate	Evaluation of LDL-C treatment target achievement rate against baseline	After more than 24 weeks of Olomax Tab. administration to 48 weeks(+8 weeks)
Secondary	Amount of blood pressure change	The amount of blood pressure change from 24 weeks to 48 weeks compared to the baseline.	at 24 weeks, at 48 weeks
Secondary	Rate of change in blood pressure	The rate of change in blood pressure and the proportion of patients who maintain the treatment goal at the point of 48 weeks or more as patients who have reached the baseline.	at 24 weeks, at 48 weeks
Secondary	The rate of patients who maintain their Blood Pressure treatment goals	The rate of patients who maintain their treatment goals at 48 weeks (who have reached their treatment goals on the baseline and the rate of change in blood pressure by anti-hypertensive drug (single, two-component complex classification))	at 24 weeks, at 48 weeks
Secondary	Blood pressure changes and treatment target attainment rate	Blood pressure changes and treatment target attainment rate at the time of more than 24 weeks and 48 weeks as patients who have not reached the baseline.	at 24 weeks, at 48 weeks
Secondary	Amount of change in blood pressure and the rate of reaching the treatment target	The amount of change in blood pressure and the rate of reaching the treatment target at the time of 48 weeks or more of the patients who have not reached the treatment target on the baseline (single, complex classification) for each anti-hypertensive drug	at 24 weeks, at 48 weeks
Secondary	The amount of LDL-C change	The amount of LDL-C change from 24 weeks to 48 weeks compared to the baseline.	at 24 weeks, at 48 weeks
Secondary	The amount of LDL-C change and percentage of patients who have reached the baseline	The amount of LDL-C change and percentage of patients who have reached the baseline and maintain the treatment goal at the point of 48 weeks or more.	at 24 weeks, at 48 weeks
Secondary	The rate of LDL-C change and rate of patients maintaining the treatment target	The rate of LDL-C change and rate of patients maintaining the treatment target at the time of 24 to 48 weeks by anti-lipidemia agent as patients who have reached the baseline.	at 24 weeks, at 48 weeks
Secondary	The amount of LDL-C change and treatment target attainment rate	The amount of LDL-C change and treatment target attainment rate at the time of more than 24 weeks and 48 weeks as patients who have not reached the baseline.	at 24 weeks, at 48 weeks
Secondary	the amount of LDL-C change and the rate of reaching the treatment target of patients who have not reached the treatment target on baseline	Patients who have not reached the treatment target on the baseline, the amount of LDL-C change and the rate of reaching the treatment target at the time of 48 weeks or more by anti-abnormal lipidemia drug	at 24 weeks, at 48 weeks
Secondary	The amount and rate of change of lipid variables	The amount and rate of change of lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks relative to the baseline.	at 24 weeks, at 48 weeks
Secondary	Framingham Risk Score (FRS) change	Framingham Risk Score (FRS) changes compared to baseline.; less than 10% : low risk; 10% to 20%: intermediate risk; over 20%: high risk	at 24 weeks, at 48 weeks
Secondary	Variation of Carotid Intima-Media Thickness Carotid Intima-Media Thickness (CIMT) levels in the presence of data	Variation of Carotid Intima-Media Thickness Carotid Intima-Media Thickness (CIMT) levels in the presence of data	at 24 weeks, at 48 weeks
Secondary	hsCRP change	hsCRP change compared to hsCRP measured at baseline visit	at 24 weeks, at 48 weeks
Secondary	Average value of medication compliance	Medication compliance at 24 weeks, at 48 weeks. The smaller the average value of medication compliance, the better the medication compliance	at 24 weeks, at 48 weeks