Trial Outcomes & Findings for To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) (NCT NCT00271817)
NCT ID: NCT00271817
Last Updated: 2024-05-16
Results Overview
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1220 participants
Primary outcome timeframe
Baseline and 24 Weeks
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Niacin
(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
|
Ezetimibe/Simvastatin
(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
Ezetimibe/Simvastatin + Niacin
(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
|---|---|---|---|
|
Part 1
STARTED
|
272
|
272
|
676
|
|
Part 1
COMPLETED
|
166
|
213
|
391
|
|
Part 1
NOT COMPLETED
|
106
|
59
|
285
|
|
Part 2
STARTED
|
0
|
266
|
485
|
|
Part 2
COMPLETED
|
0
|
234
|
401
|
|
Part 2
NOT COMPLETED
|
0
|
32
|
84
|
Reasons for withdrawal
| Measure |
Niacin
(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
|
Ezetimibe/Simvastatin
(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
Ezetimibe/Simvastatin + Niacin
(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
|---|---|---|---|
|
Part 1
Adverse Event
|
68
|
25
|
156
|
|
Part 1
Lost to Follow-up
|
6
|
8
|
24
|
|
Part 1
Protocol Violation
|
5
|
4
|
7
|
|
Part 1
Patient Moved
|
3
|
1
|
5
|
|
Part 1
Withdrawal by Subject
|
23
|
17
|
45
|
|
Part 1
LDL < 50 mg/dL
|
1
|
4
|
48
|
|
Part 2
Adverse Event
|
0
|
17
|
33
|
|
Part 2
Lack of Efficacy
|
0
|
1
|
6
|
|
Part 2
Lost to Follow-up
|
0
|
6
|
18
|
|
Part 2
Protocol Violation
|
0
|
3
|
5
|
|
Part 2
Patient Moved
|
0
|
0
|
5
|
|
Part 2
Withdrawal by Subject
|
0
|
2
|
13
|
|
Part 2
LDL < 50 mg/dL
|
0
|
3
|
4
|
Baseline Characteristics
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Niacin
n=272 Participants
(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
|
Ezetimibe/Simvastatin
n=272 Participants
(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
Ezetimibe/Simvastatin + Niacin
n=676 Participants
(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
|
Total
n=1220 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
57.5 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
56.9 years
STANDARD_DEVIATION 10.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
352 Participants
n=27 Participants
|
608 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
324 Participants
n=27 Participants
|
612 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 participants
n=93 Participants
|
4 participants
n=4 Participants
|
11 participants
n=27 Participants
|
26 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 participants
n=93 Participants
|
17 participants
n=4 Participants
|
38 participants
n=27 Participants
|
68 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=93 Participants
|
11 participants
n=4 Participants
|
49 participants
n=27 Participants
|
74 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
5 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
231 participants
n=93 Participants
|
240 participants
n=4 Participants
|
576 participants
n=27 Participants
|
1047 participants
n=483 Participants
|
|
Body Mass Index
<25 kg/m2
|
48 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
222 Participants
n=483 Participants
|
|
Body Mass Index
25 to <30 kg/m2
|
110 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
252 Participants
n=27 Participants
|
481 Participants
n=483 Participants
|
|
Body Mass Index
30 to <40 kg/m2
|
97 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
442 Participants
n=483 Participants
|
|
Body Mass Index
≥ 40 kg/m2
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
|
Body Mass Index
No BMI Data
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksPopulation: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
Outcome measures
| Measure |
Niacin
n=166 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-20.1 Percent change
Standard Error 1.3
|
-58.5 Percent change
Standard Error 0.8
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=212 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-53.5 Percent change
Standard Error 1.2
|
-58.5 Percent change
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=166 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
|
-22.0 Percent change
Standard Error 1.3
|
-55.6 Percent change
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=212 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
|
8.1 Percent change
Standard Error 1.3
|
30.2 Percent change
Standard Error 1.0
|
SECONDARY outcome
Timeframe: baseline and 24 WeeksPopulation: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=212 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG)
|
23.7 Percent change
Standard Deviation 29.7
|
-42.5 Percent change
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: Baseline and 64 weeksPopulation: The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=207 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=369 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
|
9.0 Percent change
Standard Error 1.4
|
30.5 Percent change
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline and 64 weeksPopulation: The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=207 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=369 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG)
|
-26.8 Percent change
Standard Deviation 32.7
|
-44.5 Percent change
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: Baseline and 64 weeksPopulation: The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=207 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=369 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
|
-45.1 Percent change
Standard Error 1.3
|
-52.4 Percent change
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline and 64 weeksPopulation: The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=207 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=369 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-49.3 Percent change
Standard Error 1.3
|
-54.0 Percent change
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Outcome measures
| Measure |
Niacin
n=212 Participants
Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
|
Ezetimibe/Simvastatin + Niacin
n=391 Participants
Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
|
-47.9 Percent change
Standard Error 1.1
|
-55.6 Percent change
Standard Error 0.8
|
Adverse Events
Niacin
Serious events: 8 serious events
Other events: 121 other events
Deaths: 0 deaths
Ezetimibe/Simvastatin
Serious events: 13 serious events
Other events: 428 other events
Deaths: 0 deaths
Ezetimibe/Simvastatin + Niacin
Serious events: 16 serious events
Other events: 185 other events
Deaths: 0 deaths
Ezetimibe/Simvastatin - Part 2
Serious events: 29 serious events
Other events: 175 other events
Deaths: 0 deaths
Ezetimibe/Simvastatin + Niacin - Part 2
Serious events: 59 serious events
Other events: 505 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Niacin
Niacin group from Part 1
|
Ezetimibe/Simvastatin
Ezetimibe/Simvastatin group from Part 1
|
Ezetimibe/Simvastatin + Niacin
Ezetimibe/Simvastatin + Niacin group from Part 1
|
Ezetimibe/Simvastatin - Part 2
EZ/Simva group from Part 2 All-Treated Patient as Treated Population
|
Ezetimibe/Simvastatin + Niacin - Part 2
Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Blood and lymphatic system disorders
Aplastic Anaemia
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/272
|
0.37%
1/272
|
0.15%
1/670
|
0.31%
1/326
|
0.13%
1/775
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.31%
1/326
|
0.26%
2/775
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.13%
1/775
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Gastrointestinal disorders
Pancreatic Mass
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
General disorders
Chest Pain
|
0.37%
1/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.13%
1/775
|
|
General disorders
Non-Cardiac Chest Pain
|
0.37%
1/272
|
0.00%
0/272
|
0.15%
1/670
|
0.31%
1/326
|
0.13%
1/775
|
|
General disorders
Pain
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Herpes Zoster Oticus
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Influenza
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Pneumonia
|
0.37%
1/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Rocky Mountain Spotted Fever
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Sepsis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Infections and infestations
Viral Labyrinthitis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.00%
0/775
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.26%
2/775
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.13%
1/775
|
|
Infections and infestations
Ligament Injury
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.13%
1/775
|
|
Investigations
Transaminases Abnormal
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
1/272
|
0.00%
0/272
|
0.30%
2/670
|
0.00%
0/326
|
0.39%
3/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.37%
1/272
|
0.00%
0/272
|
0.00%
0/670
|
0.61%
2/326
|
0.26%
2/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/272
|
0.00%
0/272
|
0.30%
2/670
|
0.31%
1/326
|
0.39%
3/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip Neoplasm Malignant Stage Unspecified
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.52%
4/775
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.74%
2/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Nervous system disorders
Cervical Cord Compression
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Nervous system disorders
Dizziness
|
0.37%
1/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.00%
0/775
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Nervous system disorders
Syncope
|
0.00%
0/272
|
0.00%
0/272
|
0.30%
2/670
|
0.00%
0/326
|
0.39%
3/775
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/272
|
0.37%
1/272
|
0.00%
0/670
|
0.31%
1/326
|
0.00%
0/775
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/272
|
0.00%
0/272
|
0.15%
1/670
|
0.00%
0/326
|
0.26%
2/775
|
|
Vascular disorders
Thrombosis
|
0.00%
0/272
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/326
|
0.13%
1/775
|
Other adverse events
| Measure |
Niacin
Niacin group from Part 1
|
Ezetimibe/Simvastatin
Ezetimibe/Simvastatin group from Part 1
|
Ezetimibe/Simvastatin + Niacin
Ezetimibe/Simvastatin + Niacin group from Part 1
|
Ezetimibe/Simvastatin - Part 2
EZ/Simva group from Part 2 All-Treated Patient as Treated Population
|
Ezetimibe/Simvastatin + Niacin - Part 2
Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
2.5%
8/326
|
1.3%
10/775
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
9/272
|
4.0%
27/670
|
3.7%
10/272
|
3.7%
12/326
|
6.1%
47/775
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
2.1%
7/326
|
0.90%
7/775
|
|
Gastrointestinal disorders
Nausea
|
2.9%
8/272
|
4.2%
28/670
|
4.0%
11/272
|
3.7%
12/326
|
4.1%
32/775
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/272
|
2.1%
14/670
|
1.8%
5/272
|
2.1%
7/326
|
2.8%
22/775
|
|
General disorders
Fatigue
|
2.6%
7/272
|
1.9%
13/670
|
2.2%
6/272
|
2.8%
9/326
|
2.3%
18/775
|
|
Infections and infestations
Bronchitis
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
3.1%
10/326
|
3.1%
24/775
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
2.5%
8/326
|
2.8%
22/775
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
9/272
|
2.4%
16/670
|
3.3%
9/272
|
4.6%
15/326
|
4.3%
33/775
|
|
Infections and infestations
Sinusitis
|
2.6%
7/272
|
3.1%
21/670
|
1.8%
5/272
|
5.2%
17/326
|
4.5%
35/775
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.8%
13/272
|
4.0%
27/670
|
3.3%
9/272
|
7.4%
24/326
|
7.2%
56/775
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
7/272
|
0.90%
6/670
|
1.1%
3/272
|
2.5%
8/326
|
1.3%
10/775
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
13/272
|
2.7%
18/670
|
2.9%
8/272
|
6.1%
20/326
|
4.0%
31/775
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
5/272
|
2.1%
14/670
|
2.6%
7/272
|
3.7%
12/326
|
3.4%
26/775
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.9%
8/272
|
1.5%
10/670
|
2.6%
7/272
|
3.4%
11/326
|
2.1%
16/775
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
3.1%
10/326
|
1.7%
13/775
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
8/272
|
2.7%
18/670
|
1.8%
5/272
|
4.3%
14/326
|
3.6%
28/775
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.6%
7/272
|
2.4%
16/670
|
2.9%
8/272
|
3.7%
12/326
|
3.2%
25/775
|
|
Nervous system disorders
Dizziness
|
2.6%
7/272
|
2.5%
17/670
|
2.2%
6/272
|
3.4%
11/326
|
3.4%
26/775
|
|
Nervous system disorders
Headache
|
2.9%
8/272
|
1.9%
13/670
|
4.4%
12/272
|
4.3%
14/326
|
2.3%
18/775
|
|
Nervous system disorders
Paraesthesia
|
0.74%
2/272
|
3.7%
25/670
|
5.1%
14/272
|
1.2%
4/326
|
3.7%
29/775
|
|
Psychiatric disorders
Insomnia
|
2.2%
6/272
|
0.90%
6/670
|
2.2%
6/272
|
2.5%
8/326
|
0.90%
7/775
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
2.5%
8/326
|
2.2%
17/775
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
1.1%
3/272
|
1.2%
8/670
|
2.2%
6/272
|
2.1%
7/326
|
1.5%
12/775
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
4/272
|
11.8%
79/670
|
12.9%
35/272
|
1.2%
4/326
|
11.1%
86/775
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
4/272
|
4.8%
32/670
|
5.5%
15/272
|
1.8%
6/326
|
5.3%
41/775
|
|
Vascular disorders
Flushing
|
5.5%
15/272
|
40.9%
274/670
|
39.7%
108/272
|
5.2%
17/326
|
37.2%
288/775
|
|
Vascular disorders
Hot Flush
|
1.1%
3/272
|
2.2%
15/670
|
1.8%
5/272
|
1.2%
4/326
|
2.3%
18/775
|
|
Vascular disorders
Hypertension
|
0.00%
0/272
|
0.00%
0/670
|
0.00%
0/272
|
2.8%
9/326
|
0.39%
3/775
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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