Trial · NCT01335997
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
NCT01335997, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143). Trials, record NCT01335997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
- NCT number
- NCT01335997
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,139 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM), Placebo Run-In, SIM-matching placebo
- First posted
- 2011-04-15
- Last updated
- 2019-02-06
- Other registries' IDs
- eudract:2011-001007-12
- Results first posted
- 2016-06-21
- Limitations and caveats
- Study was terminated for business reasons.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels | Baseline and Week 12 and Week 20 | Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III. |
| Secondary | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels | Baseline and Week 12 and Week 20 | Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels | Baseline and Week 12 and Week 20 | Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations. | ||
| SECONDARY | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels | Baseline and Week 12 and Week 20 | Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I and II | STARTED | ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1) | 577 | |
| Period I and II | STARTED | ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2) | 562 | |
| Period I and II | COMPLETED | ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1) | 84 | |
| Period I and II | COMPLETED | ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2) | 83 | |
| Period I and II | NOT COMPLETED | ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1) | 493 | |
| Period I and II | NOT COMPLETED | ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2) | 479 | |
| Period III | STARTED | ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1) | 84 | |
| Period III | STARTED | ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2) | 83 | |
| Period III | COMPLETED | ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1) | 6 | |
| Period III | COMPLETED | ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2) | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events88
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 | Pruritus | Skin and subcutaneous tissue disorders | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 39 | 567 | 43 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | 29 | 554 | 33 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 0 | 83 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM | 0 | 82 | 0 |
| other | Flushing | Vascular disorders | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 78 | 567 | 90 |
| other | Flushing | Vascular disorders | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | 72 | 554 | 78 |
| other | Flushing | Vascular disorders | Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 0 | 83 | 0 |
| other | Flushing | Vascular disorders | Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM | 0 | 82 | 0 |
| serious | Angina pectoris | Cardiac disorders | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 1 | 567 | 1 |
| serious | Angina pectoris | Cardiac disorders | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | 0 | 554 | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | ||
| Total, all-cause mortality | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | ||
| Total, all-cause mortality | Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | ||
| Total, all-cause mortality | Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM | ||
| Total, other adverse events | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 103 | 567 |
| Total, other adverse events | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | 95 | 554 |
| Total, other adverse events | Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 0 | 83 |
| Total, other adverse events | Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM | 0 | 82 |
| Total, serious adverse events | Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA | 11 | 567 |
| Total, serious adverse events | Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM | 5 | 554 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01335997
GET https://conductscience.org/api/trials/v1/NCT01335997/events?page=2