Trial · NCT00271817
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
NCT00271817, Phase 3, Completed, Organon and Co; results first posted 2009-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED). Trials, record NCT00271817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00271817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
- NCT number
- NCT00271817
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,220 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia
- Interventions
Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: Placebo to ezetimibe/simvastatin, Comparator: niacin (ER) tablet, Comparator: ezetimibe (+) simvastatin, Comparator: Placebo to Niacin (ER), Comparator: ezetimibe/simvastatin and niacin (ER), Comparator: ezetimibe and simvastatin, Comparator: Placebo to niacin (ER)
- First posted
- 2006-01-04
- Last updated
- 2024-05-16
- Results first posted
- 2009-08-03
- Limitations and caveats
Part 1 population is all patients enrolled in Part 1 of the study. Part 2 is those patients who received either niacin, ezetimibe/simvastatin, or ezetimibe/simvastatin + niacin during Part 1 until they finished the study at week 64 or discontinued.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 24 Weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline |
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 24 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 24 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline and 24 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline |
| Secondary | Percent Change From Baseline in Triglycerides (TG) | baseline and 24 Weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline and 64 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline |
| Secondary | Percent Change From Baseline in Triglycerides (TG) | Baseline and 64 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 64 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 64 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 24 weeks | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 24 Weeks | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 24 weeks | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline and 24 weeks | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) | baseline and 24 Weeks | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline and 64 weeks | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) | Baseline and 64 weeks | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 64 weeks | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 64 weeks | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and 24 weeks | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline and 24 weeks | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Niacin | -20.1 | Standard Error 1.3 | Percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/Simvastatin + Niacin | -58.5 | Standard Error 0.8 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Niacin | -22.0 | Standard Error 1.3 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/Simvastatin + Niacin | -55.6 | Standard Error 0.8 | Percent change | |
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/Simvastatin | 8.1 | Standard Error 1.3 | Percent change | |
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/Simvastatin + Niacin | 30.2 | Standard Error 1.0 | Percent change | |
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/Simvastatin | 23.7 | Standard Deviation 29.7 | Percent change | |
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/Simvastatin + Niacin | -42.5 | Standard Deviation 27.5 | Percent change | |
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/Simvastatin | 9.0 | Standard Error 1.4 | Percent change | |
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/Simvastatin + Niacin | 30.5 | Standard Error 1.1 | Percent change |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Niacin | 272 | |
| Part 1 | STARTED | Ezetimibe/Simvastatin | 272 | |
| Part 1 | STARTED | Ezetimibe/Simvastatin + Niacin | 676 | |
| Part 1 | COMPLETED | Niacin | 166 | |
| Part 1 | COMPLETED | Ezetimibe/Simvastatin | 213 | |
| Part 1 | COMPLETED | Ezetimibe/Simvastatin + Niacin | 391 | |
| Part 1 | NOT COMPLETED | Niacin | 106 | |
| Part 1 | NOT COMPLETED | Ezetimibe/Simvastatin | 59 | |
| Part 1 | NOT COMPLETED | Ezetimibe/Simvastatin + Niacin | 285 | |
| Part 2 | STARTED | Niacin | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events475
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 |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Niacin | 0 | 272 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe/Simvastatin | 0 | 670 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe/Simvastatin + Niacin | 0 | 272 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe/Simvastatin - Part 2 | 8 | 326 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe/Simvastatin + Niacin - Part 2 | 10 | 775 | |
| other | Diarrhoea | Gastrointestinal disorders | Niacin | 9 | 272 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe/Simvastatin | 27 | 670 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe/Simvastatin + Niacin | 10 | 272 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe/Simvastatin - Part 2 | 12 | 326 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe/Simvastatin + Niacin - Part 2 | 47 | 775 |
1 to 10 of 475Source ClinicalTrials.gov
See all 475 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Niacin | ||
| Total, all-cause mortality | Ezetimibe/Simvastatin | ||
| Total, all-cause mortality | Ezetimibe/Simvastatin + Niacin | ||
| Total, all-cause mortality | Ezetimibe/Simvastatin - Part 2 | ||
| Total, all-cause mortality | Ezetimibe/Simvastatin + Niacin - Part 2 | ||
| Total, other adverse events | Niacin | 121 | |
| Total, other adverse events | Ezetimibe/Simvastatin | 428 | |
| Total, other adverse events | Ezetimibe/Simvastatin + Niacin | 185 | |
| Total, other adverse events | Ezetimibe/Simvastatin - Part 2 | 175 | |
| Total, other adverse events | Ezetimibe/Simvastatin + Niacin - Part 2 | 505 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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.
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