Trial · NCT01381679
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
NCT01381679, Completed, Organon and Co; results first posted 2012-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1). Trials, record NCT01381679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01381679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
- NCT number
- NCT01381679
- Status
- Completed
- Enrollment
- 1,682 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
- Ezetimibe
- First posted
- 2011-06-27
- Last updated
- 2022-02-09
- Results first posted
- 2012-03-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | Up to 12 months | Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively |
| Secondary | Change From Baseline in Total Cholesterol (TC) at Month 3 | Baseline and Month 3 | |
| Secondary | Change From Baseline in TC at Month 12 | Baseline and Month 12 | |
| Secondary | Change From Baseline in LDL-C at Month 3 | Baseline and Month 3 | |
| Secondary | Change From Baseline in LDL-C at Month 12 | Baseline and Month 12 | |
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | Baseline and Month 3 | |
| Secondary | Change From Baseline in HDL-C at Month 12 | Baseline and Month 12 | |
| Secondary | Change From Baseline in Triglycerides (TG) at Month 3 | Baseline and Month 3 | |
| Secondary | Change From Baseline in TG at Month 12 | Baseline and Month 12 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | Up to 12 months | Participants | NUMBER | |
| SECONDARY | Change From Baseline in Total Cholesterol (TC) at Month 3 | Baseline and Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in TC at Month 12 | Baseline and Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in LDL-C at Month 3 | Baseline and Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in LDL-C at Month 12 | Baseline and Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | Baseline and Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in HDL-C at Month 12 | Baseline and Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Triglycerides (TG) at Month 3 | Baseline and Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in TG at Month 12 | Baseline and Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | All Participants | 678 | Participants | ||
| Change From Baseline in Total Cholesterol (TC) at Month 3 | All Participants | -46.6 | 95% Confidence Interval 40.5 | mg/dL | |
| Change From Baseline in TC at Month 12 | All Participants | -54.5 | 95% Confidence Interval 37.62 | mg/dL | |
| Change From Baseline in LDL-C at Month 3 | All Participants | -41.7 | 95% Confidence Interval 31.81 | mg/dL | |
| Change From Baseline in LDL-C at Month 12 | All Participants | -49.3 | 95% Confidence Interval 26.64 | mg/dL | |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | All Participants | 2.8 | 95% Confidence Interval 14.17 | mg/dL | |
| Change From Baseline in HDL-C at Month 12 | All Participants | 4.0 | 95% Confidence Interval 15.05 | mg/dL | |
| Change From Baseline in Triglycerides (TG) at Month 3 | All Participants | -33.8 | 95% Confidence Interval 82.51 | mg/dL | |
| Change From Baseline in TG at Month 12 | All Participants | -43.9 | 95% Confidence Interval 75.06 | mg/dL |
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 | All Participants | 1,682 | |
| Overall Study | COMPLETED | All Participants | 794 | |
| Overall Study | NOT COMPLETED | All Participants | 888 |
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 | Cholecystitis | Hepatobiliary disorders | All Participants | 1 | 1,682 | 1 |
| serious | Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | All Participants | 1 | 1,682 | 1 |
| serious | Bronchial Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | All Participants | 1 | 1,682 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 0 | 1,682 |
| Total, serious adverse events | All Participants | 3 | 1,682 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01381679
GET https://conductscience.org/api/trials/v1/NCT01381679/registered