Trial Outcomes & Findings for Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED) (NCT NCT00409773)

NCT ID: NCT00409773

Last Updated: 2024-05-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1143 participants
• Primary outcome timeframe: Baseline and 6 Weeks
• Results posted on: 2024-05-16

Participant Flow

Phase III First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008 110 centers worldwide (International, 12 countries) Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease.

Patients were randomized to 1 of 5 treatment groups: ezetimibe/simvastatin combination tablet or atorvastatin alone for 6 weeks stratified according to their baseline risk category stratum (high risk patients with atherosclerotic vascular disease or high risk patients without atherosclerotic vascular disease and moderately high risk patients).

Participant milestones

Measure	Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks
Overall Study STARTED	229	229	229	228	228
Overall Study COMPLETED	220	222	220	216	218
Overall Study NOT COMPLETED	9	7	9	12	10

Reasons for withdrawal

Measure	Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks
Overall Study Adverse Event	3	4	4	2	6
Overall Study Lost to Follow-up	6	1	2	3	1
Overall Study Physician Decision	0	0	0	2	0
Overall Study Protocol Violation	0	2	3	3	1
Overall Study Withdrawal by Subject	0	0	0	2	1
Overall Study Lack of Eligibility	0	0	0	0	1

Baseline Characteristics

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Baseline characteristics by cohort

Measure	Atorva 10 mg n=229 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=229 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=229 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=228 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=228 Participants Atorvastatin 40 mg once daily for 6 weeks	Total n=1143 Participants Total of all reporting groups
Age, Continuous	59.7 years n=93 Participants	59.7 years n=4 Participants	58.2 years n=27 Participants	59.5 years n=483 Participants	58.4 years n=36 Participants	59.1 years n=10 Participants
Sex: Female, Male Female	97 Participants n=93 Participants	87 Participants n=4 Participants	106 Participants n=27 Participants	104 Participants n=483 Participants	104 Participants n=36 Participants	498 Participants n=10 Participants
Sex: Female, Male Male	132 Participants n=93 Participants	142 Participants n=4 Participants	123 Participants n=27 Participants	124 Participants n=483 Participants	124 Participants n=36 Participants	645 Participants n=10 Participants
Race/Ethnicity, Customized Asian	17 participants n=93 Participants	15 participants n=4 Participants	15 participants n=27 Participants	18 participants n=483 Participants	21 participants n=36 Participants	86 participants n=10 Participants
Race/Ethnicity, Customized Black	13 participants n=93 Participants	18 participants n=4 Participants	18 participants n=27 Participants	12 participants n=483 Participants	14 participants n=36 Participants	75 participants n=10 Participants
Race/Ethnicity, Customized Other	27 participants n=93 Participants	27 participants n=4 Participants	19 participants n=27 Participants	27 participants n=483 Participants	26 participants n=36 Participants	126 participants n=10 Participants
Race/Ethnicity, Customized White	172 participants n=93 Participants	169 participants n=4 Participants	177 participants n=27 Participants	171 participants n=483 Participants	167 participants n=36 Participants	856 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=215 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6	-36.5 Percent Change Interval -38.9 to -34.0	-49.6 Percent Change Interval -52.0 to -47.2	-39.4 Percent Change Interval -41.8 to -36.9	-53.9 Percent Change Interval -56.4 to -51.5	-46.0 Percent Change Interval -48.4 to -43.6

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=220 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=218 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6	-26.5 Percent Change Interval -28.2 to -24.7	-33.7 Percent Change Interval -35.4 to -31.9	-28.3 Percent Change Interval -30.1 to -26.6	-37.3 Percent Change Interval -39.0 to -35.5	-32.8 Percent Change Interval -34.6 to -31.1

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=220 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=218 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6	-21.7 Percent Change Interval -25.0 to -17.9	-23.3 Percent Change Interval -26.9 to -18.2	-27.5 Percent Change Interval -30.8 to -22.4	-29.5 Percent Change Interval -32.5 to -25.0	-30.0 Percent Change Interval -34.2 to -26.5

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6	3.4 Percent Change Interval 1.5 to 5.3	6.8 Percent Change Interval 4.9 to 8.7	5.6 Percent Change Interval 3.7 to 7.5	8.8 Percent Change Interval 6.9 to 10.7	4.9 Percent Change Interval 3.0 to 6.8

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6	-33.5 Percent Change Interval -35.6 to -31.3	-43.8 Percent Change Interval -45.9 to -41.7	-36.5 Percent Change Interval -38.6 to -34.4	-48.3 Percent Change Interval -50.5 to -46.2	-41.4 Percent Change Interval -43.6 to -39.3

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=209 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=214 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=216 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6	-17.7 Percent Change Interval -21.4 to -14.0	-18.3 Percent Change Interval -22.0 to -14.7	-21.6 Percent Change Interval -25.3 to -17.8	-23.4 Percent Change Interval -27.1 to -19.7	-22.7 Percent Change Interval -26.4 to -19.0

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=211 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=218 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=213 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=214 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=216 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6	-27.9 Percent Change Interval -29.9 to -25.9	-37.2 Percent Change Interval -39.2 to -35.3	-31.9 Percent Change Interval -33.9 to -29.9	-41.1 Percent Change Interval -43.1 to -39.1	-35.8 Percent Change Interval -37.8 to -33.8

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=211 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=213 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=214 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=216 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6	0.8 Percent Change Interval -1.0 to 2.5	3.2 Percent Change Interval 1.5 to 4.9	1.0 Percent Change Interval -0.7 to 2.7	3.0 Percent Change Interval 1.3 to 4.7	1.4 Percent Change Interval -0.3 to 3.1

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6	-28.1 Percent Change Interval -30.1 to -26.0	-36.9 Percent Change Interval -38.9 to -34.8	-31.5 Percent Change Interval -33.6 to -29.5	-41.2 Percent Change Interval -43.2 to -39.1	-35.3 Percent Change Interval -37.3 to -33.2

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=215 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6	-37.8 Percent Change Interval -40.3 to -35.2	-51.8 Percent Change Interval -54.3 to -49.3	-42.1 Percent Change Interval -44.7 to -39.6	-56.6 Percent Change Interval -59.2 to -54.1	-48.2 Percent Change Interval -50.7 to -45.6

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=211 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=218 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=213 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=214 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=216 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6	-27.4 Percent Change Interval -29.6 to -25.2	-38.4 Percent Change Interval -40.6 to -36.2	-32.0 Percent Change Interval -34.2 to -29.8	-41.9 Percent Change Interval -44.1 to -39.7	-36.2 Percent Change Interval -38.4 to -34.0

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=215 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=219 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=216 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=217 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=217 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6	-34.7 Percent Change Interval -37.2 to -32.2	-46.2 Percent Change Interval -48.6 to -43.7	-39.2 Percent Change Interval -41.7 to -36.7	-51.2 Percent Change Interval -53.7 to -48.7	-43.5 Percent Change Interval -46.0 to -41.0

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=64 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=71 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=59 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=61 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=63 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)	-37.1 Percent Change Interval -41.4 to -32.7	-48.7 Percent Change Interval -52.8 to -44.6	-36.9 Percent Change Interval -41.5 to -32.4	-56.1 Percent Change Interval -60.6 to -51.7	-45.8 Percent Change Interval -50.2 to -41.5

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=151 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=148 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=156 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=156 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=154 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)	-36.3 Percent Change Interval -39.1 to -33.5	-50.1 Percent Change Interval -52.9 to -47.2	-40.3 Percent Change Interval -43.1 to -37.6	-53.2 Percent Change Interval -55.9 to -50.4	-46.1 Percent Change Interval -48.9 to -43.3

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Outcome measures

Measure	Atorva 10 mg n=216 Participants Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg n=218 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg n=210 Participants Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg n=216 Participants Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg n=215 Participants Atorvastatin 40 mg once daily for 6 weeks
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6	-16.8 Percent Change Interval -21.7 to -10.6	-17.2 Percent Change Interval -24.1 to -12.5	-22.4 Percent Change Interval -26.1 to -14.6	-27.6 Percent Change Interval -33.3 to -21.4	-30.0 Percent Change Interval -33.3 to -25.0

Adverse Events

Atorva 10 mg

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

EZ/Simva 10 mg/20 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Atorva 20mg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

EZ/Simva 10 mg/40 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Atorva 40 mg

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks
Cardiac disorders Acute Myocardial Infarction	0.44% 1/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.00% 0/224
Cardiac disorders Atrial Fibrillation	0.44% 1/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.00% 0/224
Cardiac disorders Atrioventricular Block Second Degree	0.00% 0/228	0.00% 0/226	0.00% 0/226	0.45% 1/224	0.00% 0/224
Cardiac disorders Sick Sinus Syndrome	0.00% 0/228	0.00% 0/226	0.44% 1/226	0.00% 0/224	0.00% 0/224
Cardiac disorders Tachyarrhythmia	0.00% 0/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.45% 1/224
Hepatobiliary disorders Cholestasis	0.00% 0/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.45% 1/224
Infections and infestations Urinary Tract Infection	0.00% 0/228	0.00% 0/226	0.44% 1/226	0.00% 0/224	0.00% 0/224
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.45% 1/224
Nervous system disorders Cerebrovascular Accident	0.00% 0/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.45% 1/224
Nervous system disorders Headache	0.44% 1/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.00% 0/224
Nervous system disorders Ischaemic Cerebral Infarction	0.44% 1/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.00% 0/224

Other adverse events

Measure	Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks	EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg	Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks	EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg	Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks
Gastrointestinal disorders Any Gastrointestinal Disorders	3.1% 7/228	2.7% 6/226	3.1% 7/226	1.8% 4/224	0.89% 2/224
Gastrointestinal disorders Abdominal Tenderness	0.44% 1/228	0.88% 2/226	1.3% 3/226	0.45% 1/224	0.00% 0/224
Gastrointestinal disorders Diarrhoea	2.2% 5/228	0.44% 1/226	1.3% 3/226	0.45% 1/224	0.45% 1/224
Gastrointestinal disorders Nausea	0.44% 1/228	1.3% 3/226	0.44% 1/226	0.89% 2/224	0.45% 1/224
General disorders Any General Disorders And Administration Site Conditions	0.88% 2/228	0.88% 2/226	0.88% 2/226	0.45% 1/224	0.00% 0/224
General disorders Fatigue	0.88% 2/228	0.88% 2/226	0.88% 2/226	0.45% 1/224	0.00% 0/224
Infections and infestations Any Infections and Infestations	0.44% 1/228	0.44% 1/226	0.88% 2/226	0.89% 2/224	0.45% 1/224
Infections and infestations Nasopharyngitis	0.44% 1/228	0.44% 1/226	0.88% 2/226	0.89% 2/224	0.45% 1/224
Musculoskeletal and connective tissue disorders Any Musculoskeletal And Connective Tissue Disorders	3.5% 8/228	3.1% 7/226	4.0% 9/226	2.2% 5/224	3.1% 7/224
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 3/228	0.44% 1/226	0.44% 1/226	0.89% 2/224	0.45% 1/224
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/228	0.88% 2/226	0.00% 0/226	1.3% 3/224	0.89% 2/224
Musculoskeletal and connective tissue disorders Muscle Spasms	0.88% 2/228	0.88% 2/226	1.3% 3/226	0.00% 0/224	0.45% 1/224
Musculoskeletal and connective tissue disorders Myalgia	1.3% 3/228	0.88% 2/226	1.3% 3/226	0.00% 0/224	1.3% 3/224
Musculoskeletal and connective tissue disorders Pain In Extremity	1.3% 3/228	0.44% 1/226	0.88% 2/226	0.45% 1/224	0.45% 1/224
Nervous system disorders Any Nervous System Disorders	1.8% 4/228	0.88% 2/226	1.8% 4/226	1.3% 3/224	0.89% 2/224
Nervous system disorders Dizziness	0.00% 0/228	0.88% 2/226	0.00% 0/226	1.3% 3/224	0.00% 0/224
Nervous system disorders Headache	1.8% 4/228	0.00% 0/226	1.8% 4/226	0.00% 0/224	0.89% 2/224
Vascular disorders Any Vascular Disorders	0.88% 2/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.89% 2/224
Vascular disorders Hypertension	0.88% 2/228	0.00% 0/226	0.00% 0/226	0.00% 0/224	0.00% 0/224

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER