Trial Outcomes & Findings for Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420) (NCT NCT00413972)
NCT ID: NCT00413972
Last Updated: 2022-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
392 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Vytorin 10/10
Ezetimibe 10 mg with Simvastatin 10 mg
|
Vytorin 10/20
Ezetimibe 10 mg with Simvastatin 20 mg
|
Vytorin 10/40
Ezetimibe 10 mg with Simvastatin 40 mg
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
98
|
98
|
|
Overall Study
COMPLETED
|
91
|
90
|
88
|
95
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
10
|
3
|
Reasons for withdrawal
| Measure |
Vytorin 10/10
Ezetimibe 10 mg with Simvastatin 10 mg
|
Vytorin 10/20
Ezetimibe 10 mg with Simvastatin 20 mg
|
Vytorin 10/40
Ezetimibe 10 mg with Simvastatin 40 mg
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
7
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
Baseline characteristics by cohort
| Measure |
Vytorin 10/10
n=97 Participants
Ezetimibe 10 mg with Simvastatin 10 mg
|
Vytorin 10/20
n=97 Participants
Ezetimibe 10 mg with Simvastatin 20 mg
|
Vytorin 10/40
n=98 Participants
Ezetimibe 10 mg with Simvastatin 40 mg
|
Placebo
n=97 Participants
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
57.4 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
56.4 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
60.2 years
STANDARD_DEVIATION 9.2 • n=483 Participants
|
58.2 years
STANDARD_DEVIATION 10.07 • n=36 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
246 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
143 Participants
n=36 Participants
|
|
Region of Enrollment
China
|
97 participants
n=93 Participants
|
97 participants
n=4 Participants
|
98 participants
n=27 Participants
|
97 participants
n=483 Participants
|
389 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: The number of participants for analysis included those from the ITT data set. 392 subjects were randomized in the study, but 3 of the randomized subjects were not treated and were excluded from the ITT data set. Therefore, only 389 subjects were included in the ITT data set.
Outcome measures
| Measure |
Vytorin 10/10
n=97 Participants
Ezetimibe 10 mg with Simvastatin 10 mg
|
Vytorin 10/20
n=97 Participants
Ezetimibe 10 mg with Simvastatin 20 mg
|
Vytorin 10/40
n=98 Participants
Ezetimibe 10 mg with Simvastatin 40 mg
|
Placebo
n=97 Participants
|
|---|---|---|---|---|
|
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment
|
-41.69 percent change of LDL-C
Standard Error 2.06
|
-46.83 percent change of LDL-C
Standard Error 2.08
|
-49.10 percent change of LDL-C
Standard Error 2.07
|
-7.53 percent change of LDL-C
Standard Error 2.04
|
Adverse Events
Vytorin 10/10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vytorin 10/20
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vytorin 10/40
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place