Trial Outcomes & Findings for Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647) (NCT NCT00909389)
NCT ID: NCT00909389
Last Updated: 2022-02-09
Results Overview
The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
COMPLETED
4748 participants
Throughout study up to Day 29 (Final Visit)
2022-02-09
Participant Flow
Participant milestones
| Measure |
Filipino Patients With Hypercholesterolemia
|
|---|---|
|
Overall Study
STARTED
|
4748
|
|
Overall Study
COMPLETED
|
4615
|
|
Overall Study
NOT COMPLETED
|
133
|
Reasons for withdrawal
| Measure |
Filipino Patients With Hypercholesterolemia
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Death
|
4
|
|
Overall Study
Poor Compliance
|
16
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
No Information
|
103
|
Baseline Characteristics
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
Baseline characteristics by cohort
| Measure |
Filipino Patients With Hypercholesterolemia
n=4748 Participants
|
|---|---|
|
Age, Continuous
|
55.53 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2400 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2348 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout study up to Day 29 (Final Visit)The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
Outcome measures
| Measure |
Filipino Patients With Hypercholesterolemia
n=4748 Participants
|
|---|---|
|
Number of Participants Who Had an Adverse Event (AE).
|
62 participants
|
Adverse Events
Filipino Patients With Hypercholesterolemia
Serious adverse events
| Measure |
Filipino Patients With Hypercholesterolemia
n=4748 participants at risk
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.02%
1/4748 • Number of events 1
|
|
General disorders
Death
|
0.04%
2/4748 • Number of events 2
|
|
General disorders
Multi-organ failure
|
0.02%
1/4748 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosures agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER