Trial · NCT00909389
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
NCT00909389, Completed, Organon and Co; results first posted 2011-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647). Trials, record NCT00909389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00909389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
- NCT number
- NCT00909389
- Status
- Completed
- Enrollment
- 4,748 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- Vytorin (R) (Ezetimibe + Simvastatin)
- First posted
- 2009-05-28
- Last updated
- 2022-02-09
- Results first posted
- 2011-10-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had an Adverse Event (AE). | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had an Adverse Event (AE). | Throughout study up to Day 29 (Final Visit) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had an Adverse Event (AE). | Filipino Patients With Hypercholesterolemia | 62 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Filipino Patients With Hypercholesterolemia | 4,748 | |
| Overall Study | COMPLETED | Filipino Patients With Hypercholesterolemia | 4,615 | |
| Overall Study | NOT COMPLETED | Filipino Patients With Hypercholesterolemia | 133 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial infarction | Cardiac disorders | Filipino Patients With Hypercholesterolemia | 1 | 4,748 | 1 |
| serious | Death | General disorders | Filipino Patients With Hypercholesterolemia | 2 | 4,748 | 2 |
| serious | Multi-organ failure | General disorders | Filipino Patients With Hypercholesterolemia | 1 | 4,748 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Filipino Patients With Hypercholesterolemia | ||
| Total, other adverse events | Filipino Patients With Hypercholesterolemia | 0 | 4,748 |
| Total, serious adverse events | Filipino Patients With Hypercholesterolemia | 4 | 4,748 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00909389
GET https://conductscience.org/api/trials/v1/NCT00909389/registered