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

Active, not recruiting

• Conditions: Hyperlipidemias; Hypertension
• Interventions: Drug: Rosuvastatin, Olmesartan Medoxomil

• Registration Number: NCT05411887
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2022-06-20
• Primary Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2845

Inclusion Criteria

1. men and women over the age of 19
2. Patients who signed a written consent form to participate in the study
3. Patients who are eligible for Olostar tablet prescription according to domestic permission

Exclusion Criteria

1. A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
2. Patients in hospital (hospitals only; nursing care facilities can be recruited)
3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental/ Olostar Tablet	Rosuvastatin, Olmesartan Medoxomil	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

Primary Outcome Measures

Name	Time	Method
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)	24 weeks	Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline
absolute change and rate of change in systolic and diastolic blood pressure	24 weeks	Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline

Secondary Outcome Measures

Name	Time	Method
Blood pressure treatment goal achievement rate	24 weeks	Blood pressure treatment goal achievement rate at 24 weeks
Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg	24 weeks	Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks
Olostar tablet compliance	24 weeks	Olostar tablet compliance at 24 weeks
Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals	24 weeks	Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals assessed 6 months after administration of Olosta tablets
LDL-C treatment goal achievement rate	24 weeks	LDL-C treatment goal achievement rate at 24 weeks
Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)	24 weeks	Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) at 24 weeks
Evaluation of variables affecting compliance and persistence with Olostar tablets	24 weeks	Evaluation of variables affecting compliance and persistence with Olostar tablets at 24 weeks
Evaluation of convenience of taking Olostar tablets	24 weeks	Evaluation of convenience of taking Olostar tablets at 24 weeks
Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets	24 weeks	Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets at 24 weeks
Olostar tablet dose change	24 weeks	Olostar tablet dose change: ① Proportion of subjects by initial dose, ② Average number of dose changes, ③ Proportion of subjects by dose at the end at 24 weeks
Olostar Tablet persistence	24 weeks	Olostar Tablet persistence: ① persistence rate; ② Median time to discontinuation; ③ Evaluation of reasons for suspension
Evaluation of compliance	24 weeks	Evaluation of compliance with therapeutic lifestyle improvement (eating habits and amount of exercise)
Assessment of Variables Influencing the Simultaneous Achievement of General	24 weeks	Assessment of Variables Influencing the Simultaneous Achievement of General Treatment Goals for Hypertension and Low-Density Lipoprotein Cholesterol (LDL-C) Treatment Goals and the Creation of a Predictive Model at 24 weeks

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of