Trial · NCT00704535
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
NCT00704535, Completed, Organon and Co; results first posted 2009-07-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED). Trials, record NCT00704535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
- NCT number
- NCT00704535
- Status
- Completed
- Enrollment
- 4,105 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
- Interventions
- Ezetimibe
- First posted
- 2008-06-25
- Last updated
- 2022-02-09
- Results first posted
- 2009-07-14
- Limitations and caveats
- Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as Measured by Number of Subjects With at Least One Adverse Event | 28 days after Visit 1 | Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event |
| Primary | Safety as Measured by Number and Type of Adverse Events. | 28 days after Visit 1 | Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events. |
| Primary | Safety as Measured by Severity of Adverse Events as Determined by the Investigator | 28 days after Visit 1 | To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator |
| Primary | Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. | 28 days after Visit 1 | To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator. |
| Primary | Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event | 28 days after Visit 1 | To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event |
| Primary | Safety as Measured by Outcome of Adverse Events | 28 days after Visit 1 | To evaluate overall safety of ezetimibe as measured by outcome of adverse events |
| Primary | Tolerability as Measured by Subject Self-assessment | 28 days after Visit 1 | Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment |
| Secondary | To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | 28 days after Visit 1 | Change in mean total cholesterol values |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety as Measured by Number of Subjects With at Least One Adverse Event | 28 days after Visit 1 | subjects | NUMBER | |
| SECONDARY | To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | 28 days after Visit 1 | All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements | mg/dL | MEAN |
| PRIMARY | Safety as Measured by Number and Type of Adverse Events. | 28 days after Visit 1 | adverse events | NUMBER | |
| PRIMARY | Safety as Measured by Severity of Adverse Events as Determined by the Investigator | 28 days after Visit 1 | adverse events | NUMBER | |
| PRIMARY | Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. | 28 days after Visit 1 | adverse events | NUMBER | |
| PRIMARY | Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event | 28 days after Visit 1 | adverse event | NUMBER | |
| PRIMARY | Safety as Measured by Outcome of Adverse Events | 28 days after Visit 1 | adverse events | NUMBER | |
| PRIMARY | Tolerability as Measured by Subject Self-assessment | 28 days after Visit 1 | subjects | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety as Measured by Number of Subjects With at Least One Adverse Event | Ezetimibe as Prescribed by the Physician in Normal Practice | 45 | subjects | ||
| To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | Ezetimibe as Prescribed by the Physician in Normal Practice | -62.70 | Standard Deviation 47.05 | mg/dL | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | gastrointestinal upset | 2 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | abdominal pain | 4 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | body weakness | 1 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | constipation | 3 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | crampy abdominal pain | 1 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | diarrhea | 6 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | dizziness | 4 | adverse events | |
| Safety as Measured by Number and Type of Adverse Events. | Ezetimibe as Prescribed by the Physician in Normal Practice | epigastric discomfort | 1 | adverse events |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe as Prescribed by the Physician in Normal Practice | 4,105 | |
| Overall Study | COMPLETED | Ezetimibe as Prescribed by the Physician in Normal Practice | 3,959 | |
| Overall Study | NOT COMPLETED | Ezetimibe as Prescribed by the Physician in Normal Practice | 146 |
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 | Sepsis | Infections and infestations | Ezetimibe as Prescribed by the Physician in Normal Practice | 1 | 4,105 | 1 |
| serious | Cerebrovascular accident | Nervous system disorders | Ezetimibe as Prescribed by the Physician in Normal Practice | 1 | 4,105 | 1 |
| serious | Haemorrhagic cerebral infarction | Nervous system disorders | Ezetimibe as Prescribed by the Physician in Normal Practice | 1 | 4,105 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ezetimibe as Prescribed by the Physician in Normal Practice | ||
| Total, other adverse events | Ezetimibe as Prescribed by the Physician in Normal Practice | 0 | 4,105 |
| Total, serious adverse events | Ezetimibe as Prescribed by the Physician in Normal Practice | 3 | 4,105 |
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/NCT00704535
GET https://conductscience.org/api/trials/v1/NCT00704535/results?page=2