Trial Outcomes & Findings for Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112) (NCT NCT00418834)
NCT ID: NCT00418834
Last Updated: 2024-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1053 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2024-05-14
Participant Flow
Phase III First Patient In: 28-Feb-2007; Last Patient Last Visit: 01-Oct-2008 143 centers worldwide (United States, Canada, Poland, Romania, Ukraine and Russia)
Patients were stratified based on baseline LDL-C levels and presence or absence of atherosclerotic vascular disease to achieve balance across treatment groups.
Participant milestones
| Measure |
Atorva 10 mg + EZ
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
526
|
527
|
|
Overall Study
COMPLETED
|
503
|
507
|
|
Overall Study
NOT COMPLETED
|
23
|
20
|
Reasons for withdrawal
| Measure |
Atorva 10 mg + EZ
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Baseline characteristics by cohort
| Measure |
Atorva 10 mg + EZ
n=526 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=527 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
Total
n=1053 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.2 years
n=5 Participants
|
71.2 years
n=7 Participants
|
71.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
277 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
490 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
503 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
1008 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
189 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
337 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
667 Participants
n=5 Participants
|
|
BMI [Body Mass Index (<30, ≥30 kg/m2)]
<30 kg/m2
|
359 Participants
n=5 Participants
|
362 Participants
n=7 Participants
|
721 Participants
n=5 Participants
|
|
BMI [Body Mass Index (<30, ≥30 kg/m2)]
≥30 kg/m2
|
165 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
BMI [Body Mass Index (<30, ≥30 kg/m2)]
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Apo lipoprotein A-I (Apo A-I)
|
164.3 mg/dL
STANDARD_DEVIATION 28.7 • n=5 Participants
|
164.4 mg/dL
STANDARD_DEVIATION 26.8 • n=7 Participants
|
164.4 mg/dL
STANDARD_DEVIATION 27.7 • n=5 Participants
|
|
Apo lipoprotein B (Apo B)
|
103.6 mg/dL
STANDARD_DEVIATION 22.8 • n=5 Participants
|
101.8 mg/dL
STANDARD_DEVIATION 21.4 • n=7 Participants
|
102.7 mg/dL
STANDARD_DEVIATION 22.1 • n=5 Participants
|
|
Apo lipoprotein B (Apo B):Apo lipoprotein A-I (Apo A-I) Ratio
|
0.6 Ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.6 Ratio
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.6 Ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
High Density Lipoprotein Cholesterol (HDL-C)
|
54.9 mg/dL
STANDARD_DEVIATION 13.6 • n=5 Participants
|
54.5 mg/dL
STANDARD_DEVIATION 12.3 • n=7 Participants
|
54.7 mg/dL
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Highly selective C-reactive protein (hs-CRP)
|
1.8 mg/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
1.9 mg/L
STANDARD_DEVIATION 2.3 • n=7 Participants
|
1.9 mg/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
|
102.9 mg/dL
STANDARD_DEVIATION 27.7 • n=5 Participants
|
101.8 mg/dL
STANDARD_DEVIATION 20.7 • n=7 Participants
|
102.3 mg/dL
STANDARD_DEVIATION 24.4 • n=5 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio
|
2.0 Ratio
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.0 Ratio
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.0 Ratio
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Non-High Density Lipoprotein Cholesterol (Non-HDL-C)
|
128.2 mg/dL
STANDARD_DEVIATION 30.6 • n=5 Participants
|
127.2 mg/dL
STANDARD_DEVIATION 25.2 • n=7 Participants
|
127.7 mg/dL
STANDARD_DEVIATION 28.1 • n=5 Participants
|
|
Non-High Density Lipoprotein Cholesterol (Non-HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ra
|
2.5 Ratio
STANDARD_DEVIATION 0.9 • n=5 Participants
|
2.5 Ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.5 Ratio
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Total Cholesterol
|
183.1 mg/dL
STANDARD_DEVIATION 31.8 • n=5 Participants
|
181.8 mg/dL
STANDARD_DEVIATION 26.1 • n=7 Participants
|
182.4 mg/dL
STANDARD_DEVIATION 29.1 • n=5 Participants
|
|
Total Cholesterol (TC):High Density Lipoprotein-C (HDL-C) Ratio
|
3.5 Ratio
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.5 Ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.5 Ratio
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Triglycerides (TG)
|
112.8 mg/dL
STANDARD_DEVIATION 55.3 • n=5 Participants
|
116.5 mg/dL
STANDARD_DEVIATION 60.0 • n=7 Participants
|
114.0 mg/dL
STANDARD_DEVIATION 56.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 6
|
-26.7 Percent Change
Interval -28.6 to -24.7
|
-12.8 Percent Change
Interval -14.8 to -10.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-22.5 Percent Change
Interval -25.0 to -19.9
|
-17.9 Percent Change
Interval -20.5 to -15.4
|
SECONDARY outcome
Timeframe: Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
<70 mg/dL
|
244 Participants
|
92 Participants
|
|
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
≥70 mg/dL
|
271 Participants
|
423 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
<70 mg/dL
|
225 Participants
|
164 Participants
|
|
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
≥70 mg/dL
|
291 Participants
|
345 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6
<100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD)
|
274 Participants
|
127 Participants
|
|
Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6
>100 mg/dL (w/o AVD) and ≥70 mg/dL (w/AVD)
|
241 Participants
|
388 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12
<100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD)
|
255 Participants
|
200 Participants
|
|
Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12
≥100 mg/dL (w/o AVD) and ≥70 mg/dL (w/ AVD)
|
261 Participants
|
309 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
|
2.5 Percent Change
Interval 1.1 to 4.0
|
0.7 Percent Change
Interval -0.8 to 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
|
2.4 Percent Change
Interval 0.9 to 3.8
|
-0.8 Percent Change
Interval -2.2 to 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
|
-23.5 Percent Change
Interval -25.2 to -21.7
|
-11.2 Percent Change
Interval -13.0 to -9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseine and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
-20.0 Percent Change
Interval -22.3 to -17.7
|
-15.8 Percent Change
Interval -18.1 to -13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=516 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) at Week 6
|
-15.9 Percent Change
Interval -17.2 to -14.6
|
-8.0 Percent Change
Interval -9.3 to -6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
|
-13.6 Percent Change
Interval -15.2 to -12.0
|
-11.6 Percent Change
Interval -13.2 to -10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=516 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG) at Week 6
|
-12.9 Percent Change
Interval -14.3 to -9.7
|
-5.7 Percent Change
Interval -8.4 to -3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12
|
-11.8 Percent Change
Interval -13.7 to -9.3
|
-8.5 Percent Change
Interval -11.3 to -7.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=507 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=514 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6
|
-16.8 Percent Change
Interval -18.5 to -15.1
|
-7.7 Percent Change
Interval -9.4 to -6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=511 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=506 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12
|
-14.0 Percent Change
Interval -16.1 to -11.9
|
-10.8 Percent Change
Interval -12.9 to -8.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=507 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=514 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6
|
-1.1 Percent Change
Interval -2.4 to 0.3
|
-1.7 Percent Change
Interval -3.0 to -0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=511 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=506 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12
|
0.7 Percent Change
Interval -0.7 to 2.1
|
-2.0 Percent Change
Interval -3.4 to -0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
|
-16.9 Percent Change
Interval -18.4 to -15.3
|
-7.9 Percent Change
Interval -9.4 to -6.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
|
-14.4 Percent Change
Interval -16.4 to -12.5
|
-9.8 Percent Change
Interval -11.8 to -7.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
|
-27.2 Percent Change
Interval -29.5 to -25.0
|
-12.6 Percent Change
Interval -14.9 to -10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
|
-22.9 Percent Change
Interval -25.9 to -20.0
|
-16.0 Percent Change
Interval -18.9 to -13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=507 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=514 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6
|
-14.8 Percent Change
Interval -16.6 to -12.9
|
-5.2 Percent Change
Interval -7.1 to -3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=511 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=506 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12
|
-13.5 Percent Change
Interval -15.7 to -11.3
|
-8.2 Percent Change
Interval -10.4 to -6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=515 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=515 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
|
-24.0 Percent Change
Interval -26.2 to -21.8
|
-11.1 Percent Change
Interval -13.3 to -8.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=516 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=509 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
|
-20.4 Percent Change
Interval -23.2 to -17.6
|
-13.8 Percent Change
Interval -16.6 to -10.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 6Population: 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 + EZ
n=497 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=500 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6
|
-13.5 Percent Change
Interval -19.6 to -6.8
|
-10.7 Percent Change
Interval -17.0 to -3.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: 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 + EZ
n=506 Participants
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
n=500 Participants
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12
|
-21.7 Percent Change
Interval -27.3 to -15.6
|
-14.6 Percent Change
Interval -20.7 to -8.0
|
Adverse Events
Atorva 10 mg + EZ
Serious events: 15 serious events
Other events: 46 other events
Deaths: 0 deaths
Atorva 20 mg / Atorva 40 mg
Serious events: 14 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorva 10 mg + EZ
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.38%
2/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Cardiac disorders
Coronary artery occlusion
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
General disorders
Chest pain
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
General disorders
Death
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Empyema
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Pneumonia
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Pyelonephritis chronic
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Dizziness
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Toxic encephalopathy
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Renal and urinary disorders
Urinary retention
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.19%
1/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.00%
0/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
Other adverse events
| Measure |
Atorva 10 mg + EZ
\[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks
|
Atorva 20 mg / Atorva 40 mg
Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.3%
7/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.57%
3/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Bronchitis
|
1.1%
6/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.57%
3/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
6/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
1.3%
7/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
7/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
1.5%
8/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Investigations
Asparate aminotransferase increased
|
0.38%
2/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.95%
5/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Investigations
Blood glucose increased
|
0.95%
5/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.38%
2/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
4/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
1.1%
6/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.95%
5/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.95%
5/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
0.76%
4/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Nervous system disorders
Headache
|
1.3%
7/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
1.3%
7/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
|
Vascular disorders
Hypertension
|
0.00%
0/526
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
1.7%
9/525
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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