Primary Hypercholesterolemia
Conditions
Keywords
heterozygous familial hypercholesterolemia, nonfamilial hypercholesterolemia
Brief summary
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.
Interventions
DRUGezetimibe
oral tablets: ezetimibe 10 mg once daily for 12 weeks
DRUGPlacebo
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
Sponsors
Merck Sharp & Dohme LLC
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Each subject may be of either sex and of any race/ethnicity, and must be \>=6 and \<=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of \>159mg/dL * Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Exclusion criteria
Each subject must not: * Have known hypersensitivity or any contraindication to ezetimibe. * Have use of any investigational drugs within 30 days of study entry. * Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial. * Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing * Have known congenital cardiac disorder. * Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH). * Be known to be human immunodeficiency virus (HIV) positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline and Week 12 | Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | Baseline and Week 12 | Serum Apo B measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Non-HDL-C at Week 12 | Baseline and 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. |
| Percentage Change From Baseline in Triglycerides (TG) at Week 12 | Baseline and Week 12 | Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug. |
| Percent Change From Baseline in LDL-C at Week 2 | Baseline and 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). |
| Percent Change From Baseline in LDL-C at Week 4 | Baseline and 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). |
| Percent Change From Baseline in LDL-C at Week 8 | Baseline and 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). |
| Percentage Change From Baseline in TC at Week 2 | Baseline and Week 2 | Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in TC at Week 4 | Baseline and Week 4 | Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in TC at Week 8 | Baseline and Week 8 | Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline HDL-C at Week 2 | Baseline and Week 2 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline HDL-C at Week 4 | Baseline and Week 4 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline HDL-C at Week 8 | Baseline and Week 8 | Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in Non-HDL-C at Week 2 | Baseline and 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. |
| Percentage Change From Baseline in Non-HDL-C at Week 4 | Baseline and 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. |
| Percentage Change From Baseline in Non-HDL-C at Week 8 | Baseline and 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. |
| Percentage Change From Baseline in TG at Week 2 | Baseline and Week 2 | Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in TG at Week 4 | Baseline and Week 4 | Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in TG at Week 8 | Baseline and Week 8 | Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 | Baseline and Week 12 | Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 | Baseline and Week 2 | Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 | Baseline and Week 4 | Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 | Baseline and Week 8 | Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 | Baseline and Week 12 | Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 | Baseline and Week 2 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 | Baseline and Week 4 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 | Baseline and Week 8 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 | Baseline and Week 12 | Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 | Baseline and Week 12 | Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration |
| Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 | Baseline and Week 4 | Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 | Baseline and Week 12 | Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration. |
| Percent Change From Baseline in Sitosterol at Week 2 | Baseline and Week 2 | Plasma sitosterol measured at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in Sitosterol at Week 4 | Baseline and Week 4 | Plasma sitosterol measured at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in Sitosterol at Week 8 | Baseline and Week 8 | Plasma sitosterol measured at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in Sitosterol at Week 12 | Baseline and Week 12 | Plasma sitosterol measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Campesterol at Week 2 | Baseline and Week 2 | Plasma campesterol measured at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in Campesterol at Week 8 | Baseline and Week 8 | Plasma campesterol measured at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in Campesterol at Week 12 | Baseline and Week 12 | Plasma campesterol measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Cholestanol at Week 2 | Baseline and Week 2 | Plasma cholestanol measured at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in Cholestanol at Week 4 | Baseline and Week 4 | Plasma cholestanol measured at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in Campesterol at Week 4 | Baseline and Week 4 | Plasma campesterol measured at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in Cholestanol at Week 12 | Baseline and Week 12 | Plasma cholestanol measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Lathosterol at Week 2 | Baseline and Week 2 | Plasma lathosterol measured at baseline and after 2 weeks of study drug administration. |
| Percentage Change From Baseline in Lathosterol at Week 4 | Baseline and Week 4 | Plasma lathosterol measured at baseline and after 4 weeks of study drug administration. |
| Percentage Change From Baseline in Lathosterol at Week 8 | Baseline and Week 8 | Plasma lathosterol measured at baseline and after 8 weeks of study drug administration. |
| Percentage Change From Baseline in Lathosterol at Week 12 | Baseline and Week 12 | Plasma lathosterol measured at baseline and after 12 weeks of study drug administration. |
| Percentage Change From Baseline in Cholestanol at Week 8 | Baseline and Week 8 | Plasma cholestanol measured at baseline and after 8 weeks of study drug administration. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe Ezetimibe 10-mg tablet once daily for 12 weeks | 93 |
| Placebo Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks | 45 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ezetimibe | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 8.2 years STANDARD_DEVIATION 1.7 | 8.5 years STANDARD_DEVIATION 1.6 | 8.3 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 52 Participants | 27 Participants | 79 Participants |
| Sex: Female, Male Male | 41 Participants | 18 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 92 | 18 / 45 |
| serious Total, serious adverse events | 2 / 92 | 0 / 45 |
Outcome results
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).
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -27.70 Percent Change |
| Placebo | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -0.95 Percent Change |
p-value: <0.00195% CI: [-30.8, -22.69]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline HDL-C at Week 2 | 0.01 Percentage Change |
| Placebo | Percentage Change From Baseline HDL-C at Week 2 | 0.96 Percentage Change |
p-value: 0.73395% CI: [-6.46, 4.55]ANCOVA
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline HDL-C at Week 4 | 0.86 Percentage Change |
| Placebo | Percentage Change From Baseline HDL-C at Week 4 | 0.33 Percentage Change |
p-value: 0.86395% CI: [-5.59, 6.66]ANCOVA
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline HDL-C at Week 8 | 1.41 Percentage Change |
| Placebo | Percentage Change From Baseline HDL-C at Week 8 | -0.52 Percentage Change |
p-value: 0.50195% CI: [-3.71, 7.56]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | 2.11 Percentage Change |
| Placebo | Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | 1.41 Percentage Change |
p-value: 0.80795% CI: [-4.97, 6.36]ANCOVA
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
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 | -22.16 Percentage Change |
| Placebo | Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 | -2.87 Percentage Change |
p-value: <0.00195% CI: [-23.87, -14.7]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 | 1.80 Percentage Change |
| Placebo | Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 | 3.71 Percentage Change |
p-value: 0.37395% CI: [-6.15, 2.32]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | -21.66 Percent Change |
| Placebo | Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | -1.42 Percent Change |
p-value: <0.00195% CI: [-24.02, -16.45]ANCOVA
Secondary
Percentage Change From Baseline in Campesterol at Week 12
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Campesterol at Week 12 | -67.59 Percentage Change |
| Placebo | Percentage Change From Baseline in Campesterol at Week 12 | -2.92 Percentage Change |
p-value: <0.00195% CI: [-74.11, -55.23]ANCOVA
Secondary
Percentage Change From Baseline in Campesterol at Week 2
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Campesterol at Week 2 | -53.87 Percentage Change |
| Placebo | Percentage Change From Baseline in Campesterol at Week 2 | -4.38 Percentage Change |
p-value: <0.00195% CI: [-54.83, -44.14]ANCOVA
Secondary
Percentage Change From Baseline in Campesterol at Week 4
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Campesterol at Week 4 | -62.27 Percentage Change |
| Placebo | Percentage Change From Baseline in Campesterol at Week 4 | -4.28 Percentage Change |
p-value: <0.00195% CI: [-62.87, -53.11]ANCOVA
Secondary
Percentage Change From Baseline in Campesterol at Week 8
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Campesterol at Week 8 | -66.79 Percentage Change |
| Placebo | Percentage Change From Baseline in Campesterol at Week 8 | -4.19 Percentage Change |
p-value: <0.00195% CI: [-68.54, -56.66]ANCOVA
Secondary
Percentage Change From Baseline in Cholestanol at Week 12
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Cholestanol at Week 12 | -28.71 Percentage Change |
| Placebo | Percentage Change From Baseline in Cholestanol at Week 12 | 3.42 Percentage Change |
p-value: <0.00195% CI: [-40.38, -23.9]ANCOVA
Secondary
Percentage Change From Baseline in Cholestanol at Week 2
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Cholestanol at Week 2 | -25.44 Percentage Change |
| Placebo | Percentage Change From Baseline in Cholestanol at Week 2 | -7.09 Percentage Change |
p-value: <0.00195% CI: [-24.7, -11.99]ANCOVA
Secondary
Percentage Change From Baseline in Cholestanol at Week 4
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Cholestanol at Week 4 | -27.40 Percentage Change |
| Placebo | Percentage Change From Baseline in Cholestanol at Week 4 | -1.79 Percentage Change |
p-value: <0.00195% CI: [-31.2, -20.02]ANCOVA
Secondary
Percentage Change From Baseline in Cholestanol at Week 8
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Cholestanol at Week 8 | -29.19 Percentage Change |
| Placebo | Percentage Change From Baseline in Cholestanol at Week 8 | -0.44 Percentage Change |
p-value: <0.00195% CI: [-34.89, -22.59]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 | 9.35 Percentage Change |
| Placebo | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 | -7.92 Percentage Change |
p-value: 0.38295% CI: [-20.46, 55]Constrained longitudinal data analysis
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 | 10.00 Percentage Change |
| Placebo | Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 | 56.11 Percentage Change |
p-value: 0.11695% CI: [-108.14, 15.92]Constrained longitudinal data analysis
Secondary
Percentage Change From Baseline in Lathosterol at Week 12
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Lathosterol at Week 12 | 36.62 Percentage Change |
| Placebo | Percentage Change From Baseline in Lathosterol at Week 12 | 12.57 Percentage Change |
p-value: <0.00195% CI: [10.43, 37.67]ANCOVA
Secondary
Percentage Change From Baseline in Lathosterol at Week 2
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Lathosterol at Week 2 | 34.07 Percentage Change |
| Placebo | Percentage Change From Baseline in Lathosterol at Week 2 | 14.06 Percentage Change |
p-value: 0.00195% CI: [8.1, 31.91]ANCOVA
Secondary
Percentage Change From Baseline in Lathosterol at Week 4
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Lathosterol at Week 4 | 33.02 Percentage Change |
| Placebo | Percentage Change From Baseline in Lathosterol at Week 4 | 6.73 Percentage Change |
p-value: <0.00195% CI: [13.99, 38.58]ANCOVA
Secondary
Percentage Change From Baseline in Lathosterol at Week 8
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Lathosterol at Week 8 | 35.87 Percentage Change |
| Placebo | Percentage Change From Baseline in Lathosterol at Week 8 | -0.82 Percentage Change |
p-value: <0.00195% CI: [24.12, 49.28]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 | -28.01 Percentage Change |
| Placebo | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 | 0.34 Percentage Change |
p-value: <0.00195% CI: [-34.41, -22.29]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 | -23.35 Percentage Change |
| Placebo | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 | 1.15 Percentage Change |
p-value: <0.00195% CI: [-29.88, -19.12]ANCOVA
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 | -25.72 Percentage Change |
| Placebo | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 | -0.57 Percentage Change |
p-value: <0.00195% CI: [-30.69, -19.62]ANCOVA
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 | -26.43 Percentage Change |
| Placebo | Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 | 2.87 Percentage Change |
p-value: <0.00195% CI: [-35.71, -22.91]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Non-HDL-C at Week 12 | -25.47 Percentage Change |
| Placebo | Percentage Change From Baseline in Non-HDL-C at Week 12 | 0.28 Percentage Change |
p-value: <0.00195% CI: [-29.59, -21.91]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Non-HDL-C at Week 2 | -22.54 Percentage Change |
| Placebo | Percentage Change From Baseline in Non-HDL-C at Week 2 | 1.64 Percentage Change |
p-value: <0.00195% CI: [-27.78, -20.58]ANCOVA
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Non-HDL-C at Week 4 | -24.94 Percentage Change |
| Placebo | Percentage Change From Baseline in Non-HDL-C at Week 4 | -0.33 Percentage Change |
p-value: <0.00195% CI: [-28.06, -21.16]ANCOVA
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Non-HDL-C at Week 8 | -25.41 Percentage Change |
| Placebo | Percentage Change From Baseline in Non-HDL-C at Week 8 | 1.14 Percentage Change |
p-value: <0.00195% CI: [-30.35, -22.75]ANCOVA
Secondary
Percentage Change From Baseline in Sitosterol at Week 12
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Sitosterol at Week 12 | -60.65 Percentage Change |
| Placebo | Percentage Change From Baseline in Sitosterol at Week 12 | 2.09 Percentage Change |
p-value: 0.00195% CI: [-73.22, -52.26]ANCOVA
Secondary
Percentage Change From Baseline in Sitosterol at Week 4
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Sitosterol at Week 4 | -58.82 Percentage Change |
| Placebo | Percentage Change From Baseline in Sitosterol at Week 4 | -0.30 Percentage Change |
p-value: <0.00195% CI: [-63.67, -53.38]ANCOVA
Secondary
Percentage Change From Baseline in Sitosterol at Week 8
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Sitosterol at Week 8 | -61.59 Percentage Change |
| Placebo | Percentage Change From Baseline in Sitosterol at Week 8 | -0.57 Percentage Change |
p-value: <0.00195% CI: [-67.51, -54.53]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC at Week 2 | -18.69 Percentage Change |
| Placebo | Percentage Change From Baseline in TC at Week 2 | 1.40 Percentage Change |
p-value: <0.00195% CI: [-23.3, -16.89]ANCOVA
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC at Week 4 | -20.57 Percentage Change |
| Placebo | Percentage Change From Baseline in TC at Week 4 | -0.29 Percentage Change |
p-value: <0.00195% CI: [-23.39, -17.15]ANCOVA
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC at Week 8 | -20.84 Percentage Change |
| Placebo | Percentage Change From Baseline in TC at Week 8 | 0.54 Percentage Change |
p-value: <0.00195% CI: [-24.67, -18.08]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 | -21.09 Percentage Change |
| Placebo | Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 | 1.20 Percentage Change |
p-value: <0.00195% CI: [-27.25, -17.34]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 | -17.21 Percentage Change |
| Placebo | Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 | 2.56 Percentage Change |
p-value: <0.00195% CI: [-24.7, -14.82]ANCOVA
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 | -19.36 Percentage Change |
| Placebo | Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 | 1.48 Percentage Change |
p-value: <0.00195% CI: [-25.59, -16.07]ANCOVA
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 | -20.07 Percentage Change |
| Placebo | Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 | 3.41 Percentage Change |
p-value: <0.00195% CI: [-29, -17.97]ANCOVA
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.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TG at Week 2 | -3.90 Percentage Change |
| Placebo | Percentage Change From Baseline in TG at Week 2 | 5.83 Percentage Change |
p-value: 0.13795% CI: [-22.73, 3.27]Constrained longitudinal data analysis
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.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TG at Week 4 | -5.54 Percentage Change |
| Placebo | Percentage Change From Baseline in TG at Week 4 | 9.65 Percentage Change |
p-value: 0.00595% CI: [-26.05, -4.34]Constrained longitudinal data analysis
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.
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in TG at Week 8 | -9.99 Percentage Change |
| Placebo | Percentage Change From Baseline in TG at Week 8 | -1.38 Percentage Change |
p-value: 0.14995% CI: [-20.44, 3.23]Constrained longitudinal data analysis
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 | -20.74 Percentage Change |
| Placebo | Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 | 0.19 Percentage Change |
p-value: <0.00195% CI: [-24.2, -17.65]ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percentage Change From Baseline in Triglycerides (TG) at Week 12 | -6.23 Percentage change |
| Placebo | Percentage Change From Baseline in Triglycerides (TG) at Week 12 | 8.44 Percentage change |
p-value: 0.02195% CI: [-27.35, -2]Constrained longitudinal data analysis
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).
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percent Change From Baseline in LDL-C at Week 2 | -24.75 Percentage Change |
| Placebo | Percent Change From Baseline in LDL-C at Week 2 | 0.23 Percentage Change |
p-value: <0.00195% CI: [-28.95, -20.99]ANCOVA
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).
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percent Change From Baseline in LDL-C at Week 4 | -26.93 Percentage Change |
| Placebo | Percent Change From Baseline in LDL-C at Week 4 | -2.99 Percentage Change |
p-value: <0.00195% CI: [-27.49, -20.39]ANCOVA
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).
Time frame: Baseline and Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percent Change From Baseline in LDL-C at Week 8 | -27.22 Percentage Change |
| Placebo | Percent Change From Baseline in LDL-C at Week 8 | 0.49 Percentage Change |
p-value: <0.00195% CI: [-31.7, -23.73]ANCOVA
Secondary
Percent Change From Baseline in Sitosterol at Week 2
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ezetimibe | Percent Change From Baseline in Sitosterol at Week 2 | -50.20 Percentage Change |
| Placebo | Percent Change From Baseline in Sitosterol at Week 2 | -0.59 Percentage Change |
p-value: <0.00195% CI: [-55.36, -43.87]ANCOVA