Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab
A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.
1 other identifier
observational
2,845
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 24, 2025
August 1, 2025
2.8 years
May 19, 2022
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline
24 weeks
absolute change and rate of change in systolic and diastolic blood pressure
Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline
24 weeks
Secondary Outcomes (13)
Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals
24 weeks
LDL-C treatment goal achievement rate
24 weeks
Blood pressure treatment goal achievement rate
24 weeks
Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg
24 weeks
Olostar tablet compliance
24 weeks
- +8 more secondary outcomes
Study Arms (1)
Experimental/ Olostar Tablet
Eligible Subjects who received Olostar Tablet treatment for 24 weeks. Dosage: 10/5mg, 10/10mg, 20/5mg, 20/10mg, 20/20mg, 40/10mg, 40/20mg
Interventions
Eligibility Criteria
3000 subjects is a sufficient number to produce a meaningful model considering discriminant analysis and regression analysis that will be conducted in the secondary evaluation
You may qualify if:
- men and women over the age of 19
- Patients who signed a written consent form to participate in the study
- Patients who are eligible for Olostar tablet prescription according to domestic permission
You may not qualify if:
- A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
- Patients in hospital (hospitals only; nursing care facilities can be recruited)
- A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JaeWon Oh
Severance Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
June 9, 2022
Study Start
June 20, 2022
Primary Completion
March 31, 2025
Study Completion
December 31, 2025
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share