Trial Outcomes & Findings for The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED) (NCT NCT00423579)
NCT ID: NCT00423579
Last Updated: 2024-05-22
Results Overview
Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2024-05-22
Participant Flow
Visits 1 and 2 were for screening, combined if wash-out not required. One ineligible subject mistakenly received assignment at Visit 2 and was removed. The subject did not receive treatment. Actual enrollment: 120 subjects. Intent-to-treat (ITT) population included only evaluable subjects; as such analysis based on 112 subjects.
Participant milestones
| Measure |
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Diagnosis of diabetes
|
0
|
1
|
Baseline Characteristics
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
n=56 Participants
Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
n=56 Participants
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Intent-to-treat population only.
Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.
Outcome measures
| Measure |
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
n=56 Participants
Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
n=56 Participants
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
|---|---|---|
|
Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks
|
-26.5 percentage change
Standard Deviation 9.5
|
-11.9 percentage change
Standard Deviation 13.6
|
Adverse Events
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo
n=60 participants at risk
Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
n=60 participants at risk
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
|---|---|---|
|
Cardiac disorders
Transient Ischemic Attack
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
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 The investigator shall not publish or publicly present the study results without prior written authorization from the sponsor, except for dispositions in the Ministerial Circular n. 6 dated 02 SEP 2002. The investigator shall notify the sponsor in writing of any publication submission or presentation reporting results of the study 30 days prior to submission or presentation to permit sponsor review.
- Publication restrictions are in place
Restriction type: OTHER