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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006271-70 | EudraCT Number | ||
| MK-0653-170 | Other Identifier | Merck Study Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe | Experimental | Ezetimibe 10-mg tablet once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe | Drug | oral tablets: ezetimibe 10 mg once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 | Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Each subject must not:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25841542 | Result | Kusters DM, Caceres M, Coll M, Cuffie C, Gagne C, Jacobson MS, Kwiterovich PO, Lee R, Lowe RS, Massaad R, McCrindle BW, Musliner TA, Triscari J, Kastelein JJ. Efficacy and safety of ezetimibe monotherapy in children with heterozygous familial or nonfamilial hypercholesterolemia. J Pediatr. 2015 Jun;166(6):1377-84.e1-3. doi: 10.1016/j.jpeds.2015.02.043. Epub 2015 Apr 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe | Ezetimibe 10-mg tablet once daily for 12 weeks |
| FG001 | Placebo | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe | Ezetimibe 10-mg tablet once daily for 12 weeks |
| BG001 | Placebo | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 12 |
|
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Safety analysis was performed on the All-Patients-as-Treated (APaT) Population defined as all randomized patients who received at least one dose of double-blind study therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ezetimibe | Ezetimibe 10-mg tablet once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilepsy congenital | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period |
|
Serum Apo B measured at baseline and after 12 weeks of study drug administration. |
| Baseline and Week 12 |
| Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Non-HDL-C at Week 12 | Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Baseline and Week 12 |
| Percentage Change From Baseline in Triglycerides (TG) at Week 12 | Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug. | Baseline and Week 12 |
| Percent Change From Baseline in LDL-C at Week 2 | Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Baseline and Week 2 |
| Percent Change From Baseline in LDL-C at Week 4 | Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Baseline and Week 4 |
| Percent Change From Baseline in LDL-C at Week 8 | Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Baseline and Week 8 |
| Percentage Change From Baseline in TC at Week 2 | Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in TC at Week 4 | Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in TC at Week 8 | Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline HDL-C at Week 2 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline HDL-C at Week 4 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline HDL-C at Week 8 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Non-HDL-C at Week 2 | Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Baseline and Week 2 |
| Percentage Change From Baseline in Non-HDL-C at Week 4 | Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Baseline and Week 4 |
| Percentage Change From Baseline in Non-HDL-C at Week 8 | Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Baseline and Week 8 |
| Percentage Change From Baseline in TG at Week 2 | Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in TG at Week 4 | Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in TG at Week 8 | Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 | Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 | Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 | Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 | Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 | Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 | Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration | Baseline and Week 12 |
| Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 | Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 | Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percent Change From Baseline in Sitosterol at Week 2 | Plasma sitosterol measured at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in Sitosterol at Week 4 | Plasma sitosterol measured at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in Sitosterol at Week 8 | Plasma sitosterol measured at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Sitosterol at Week 12 | Plasma sitosterol measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Campesterol at Week 2 | Plasma campesterol measured at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in Campesterol at Week 4 | Plasma campesterol measured at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in Campesterol at Week 8 | Plasma campesterol measured at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Campesterol at Week 12 | Plasma campesterol measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Cholestanol at Week 2 | Plasma cholestanol measured at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in Cholestanol at Week 4 | Plasma cholestanol measured at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in Cholestanol at Week 8 | Plasma cholestanol measured at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Cholestanol at Week 12 | Plasma cholestanol measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| Percentage Change From Baseline in Lathosterol at Week 2 | Plasma lathosterol measured at baseline and after 2 weeks of study drug administration. | Baseline and Week 2 |
| Percentage Change From Baseline in Lathosterol at Week 4 | Plasma lathosterol measured at baseline and after 4 weeks of study drug administration. | Baseline and Week 4 |
| Percentage Change From Baseline in Lathosterol at Week 8 | Plasma lathosterol measured at baseline and after 8 weeks of study drug administration. | Baseline and Week 8 |
| Percentage Change From Baseline in Lathosterol at Week 12 | Plasma lathosterol measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
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| Secondary | Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 | Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | Serum Apo B measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Non-HDL-C at Week 12 | Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Triglycerides (TG) at Week 12 | Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
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| Secondary | Percent Change From Baseline in LDL-C at Week 2 | Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percent Change From Baseline in LDL-C at Week 4 | Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percent Change From Baseline in LDL-C at Week 8 | Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5). | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in TC at Week 2 | Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in TC at Week 4 | Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in TC at Week 8 | Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline HDL-C at Week 2 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline HDL-C at Week 4 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline HDL-C at Week 8 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Non-HDL-C at Week 2 | Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in Non-HDL-C at Week 4 | Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in Non-HDL-C at Week 8 | Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in TG at Week 2 | Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in TG at Week 4 | Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in TG at Week 8 | Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 | Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 | Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 | Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 | Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 | Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 | Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 | Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 | Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percent Change From Baseline in Sitosterol at Week 2 | Plasma sitosterol measured at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in Sitosterol at Week 4 | Plasma sitosterol measured at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in Sitosterol at Week 8 | Plasma sitosterol measured at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Sitosterol at Week 12 | Plasma sitosterol measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Campesterol at Week 2 | Plasma campesterol measured at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in Campesterol at Week 4 | Plasma campesterol measured at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in Campesterol at Week 8 | Plasma campesterol measured at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Campesterol at Week 12 | Plasma campesterol measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Cholestanol at Week 2 | Plasma cholestanol measured at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in Cholestanol at Week 4 | Plasma cholestanol measured at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in Cholestanol at Week 8 | Plasma cholestanol measured at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Cholestanol at Week 12 | Plasma cholestanol measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| Secondary | Percentage Change From Baseline in Lathosterol at Week 2 | Plasma lathosterol measured at baseline and after 2 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 2 |
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| Secondary | Percentage Change From Baseline in Lathosterol at Week 4 | Plasma lathosterol measured at baseline and after 4 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 4 |
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| Secondary | Percentage Change From Baseline in Lathosterol at Week 8 | Plasma lathosterol measured at baseline and after 8 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 8 |
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| Secondary | Percentage Change From Baseline in Lathosterol at Week 12 | Plasma lathosterol measured at baseline and after 12 weeks of study drug administration. | Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
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| 2 |
| 92 |
| 27 |
| 92 |
| EG001 | Placebo | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks | 0 | 45 | 18 | 45 |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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The investigator agreed not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agreed to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.