Trial Outcomes & Findings for Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) (NCT NCT03768427)
NCT ID: NCT03768427
Last Updated: 2024-05-16
Results Overview
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
Baseline (Day 1) and Week 12
Results posted on
2024-05-16
Participant Flow
Chinese participants with Hypercholesterolemia inadequately controlled with 10 mg or 20 mg atorvastatin (Ator) monotherapy were enrolled.
Participant milestones
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
89
|
137
|
140
|
|
Overall Study
COMPLETED
|
76
|
85
|
126
|
129
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
11
|
11
|
Reasons for withdrawal
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
6
|
7
|
Baseline Characteristics
Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
Baseline characteristics by cohort
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=88 Participants
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=89 Participants
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=137 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=140 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
59.4 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
60.9 Years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
293 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
454 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
454 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
95.5 mg/dL
STANDARD_DEVIATION 24.6 • n=5 Participants
|
96.8 mg/dL
STANDARD_DEVIATION 25.9 • n=7 Participants
|
96.2 mg/dL
STANDARD_DEVIATION 25.2 • n=5 Participants
|
88.4 mg/dL
STANDARD_DEVIATION 21.9 • n=4 Participants
|
91.9 mg/dL
STANDARD_DEVIATION 24.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: All randomized participants who took at least one dose of study treatment, and have at least one post treatment observation of the respective endpoint (Baseline and Week 12) during the treatment period.
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
Outcome measures
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=67 Participants
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=77 Participants
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=114 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=116 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12
|
-24.7 Percent change
Standard Deviation 24.9
|
-5.3 Percent change
Standard Deviation 22.5
|
-23.3 Percent change
Standard Deviation 23.1
|
-9.1 Percent change
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Up to approximately 17 weeksPopulation: All randomized participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Outcome measures
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=88 Participants
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=89 Participants
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=137 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=140 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Percentage of Participants With An Adverse Event (AE)
|
31.8 Percentage of Participants
|
34.8 Percentage of Participants
|
55.5 Percentage of Participants
|
47.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to approximately 15 weeksPopulation: All randomized participants who received at least one dose of study treatment.
The number of participants who discontinued treatment over the 12-week treatment period was assessed.
Outcome measures
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=88 Participants
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=89 Participants
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=137 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=140 Participants
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued From Study Treatment
|
9 Number of Participants
|
5 Number of Participants
|
13 Number of Participants
|
15 Number of Participants
|
Adverse Events
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Atorvastatin 10mg - Atorvastatin 20 mg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
Serious events: 10 serious events
Other events: 7 other events
Deaths: 1 deaths
Atorvastatin 20 mg - Atorvastatin 40 mg
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=88 participants at risk
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=89 participants at risk
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=137 participants at risk
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=140 participants at risk
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.4%
2/140 • Number of events 2 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.71%
1/140 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.5%
2/137 • Number of events 2 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.1%
1/89 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Eye disorders
Cataract
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.1%
1/89 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.71%
1/140 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.71%
1/140 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.71%
1/140 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa cell tumour
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Nervous system disorders
Cerebral infarction
|
2.3%
2/88 • Number of events 2 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.1%
1/89 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.1%
1/89 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.1%
1/89 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/137 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.73%
1/137 • Number of events 1 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/140 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
Other adverse events
| Measure |
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg
n=88 participants at risk
Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 10mg - Atorvastatin 20 mg
n=89 participants at risk
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg
n=137 participants at risk
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
Atorvastatin 20 mg - Atorvastatin 40 mg
n=140 participants at risk
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/88 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
0.00%
0/89 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
5.1%
7/137 • Number of events 7 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
1.4%
2/140 • Number of events 2 • Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER