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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin, Olmesartan Medoxomil | Drug | Olostar Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals | 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 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| JaeWon Oh | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| LDL-C treatment goal achievement rate | LDL-C treatment goal achievement rate at 24 weeks | 24 weeks |
| Blood pressure treatment goal achievement rate | Blood pressure treatment goal achievement rate at 24 weeks | 24 weeks |
| Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg | Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks | 24 weeks |
| Olostar tablet compliance | Olostar tablet compliance at 24 weeks | 24 weeks |
| Olostar tablet dose change | 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 | 24 weeks |
| Olostar Tablet persistence | Olostar Tablet persistence: ① persistence rate; ② Median time to discontinuation; ③ Evaluation of reasons for suspension | 24 weeks |
| Evaluation of compliance | Evaluation of compliance with therapeutic lifestyle improvement (eating habits and amount of exercise) | 24 weeks |
| Assessment of Variables Influencing the Simultaneous Achievement of General | 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 | 24 weeks |
| Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) | Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) at 24 weeks | 24 weeks |
| Evaluation of variables affecting compliance and persistence with Olostar tablets | Evaluation of variables affecting compliance and persistence with Olostar tablets at 24 weeks | 24 weeks |
| Evaluation of convenience of taking Olostar tablets | Evaluation of convenience of taking Olostar tablets at 24 weeks | 24 weeks |
| Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets | Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets at 24 weeks | 24 weeks |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
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