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A multicenter, randomized, double-blind, phase â…£ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides
A multicenter study to evaluate efficacy and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin/Ezetimibe Combination | Experimental | FDC of Pitavastatin/Ezetimibe |
|
| Pitavastatin Monotherapy | Active Comparator | Pitavastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin 4mg | Drug | Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment | The unit of measure is percentage (%). The percentage change is calculated as: [(Value at Week 8 - Value at Baseline) / Value at Baseline] * 100 | Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment | Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL | Baseline to week 8, 24, 52 |
| Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyuk Sang Kwon | The Catholic University of Korea, Yeouido St. Mary's Hospital, Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | South Korea |
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randomized, double-blind, phase IV
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To maintain the double-blind, a double-dummy method was used where participants received both an active tablet and a matching placebo of the comparator
| Ezetimibe 10 mg | Drug | Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks. |
|
| Placebo (for Pitavastatin/Ezetimibe) | Drug | Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks. |
|
| Placebo (for Pitavastatin) | Drug | Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks. |
|
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL |
| Baseline to week 8, 24, 52 |
| Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment | Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL | Baseline to week 8, 24, 52 |
| Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52 | The NLFS is a calculated score used to estimate liver fat content. The change is calculated as (Value at Week 24 or 52) - (Value at Baseline). | Baseline to week 24, 52 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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