Trial · NCT01274559
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
NCT01274559, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2014-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133). Trials, record NCT01274559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01274559
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
- NCT number
- NCT01274559
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,173 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- Extended-release niacin/laropiprant (ERN/LRPT), Placebo
- First posted
- 2011-01-11
- Last updated
- 2024-05-22
- Other registries' IDs
- eudract:2010-021627-27
- Results first posted
- 2014-03-14
- Limitations and caveats
- MK-0524A-133 was stopped prior to completion. Raw individual efficacy data were obtained but none of planned efficacy outcomes were summarized or analyzed. Only safety data were summarized.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in HDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Triglyceride (TG) at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Apo A-I at Week 12 | Baseline and Week 12 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
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 at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in HDL-C at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Triglyceride (TG) at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. | ||
| SECONDARY | Percent Change From Baseline in Apo A-I at Week 12 | Baseline and Week 12 | Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended-release Niacin/Laropiprant | 587 | |
| Overall Study | STARTED | Placebo | 586 | |
| Overall Study | Treated | Extended-release Niacin/Laropiprant | 572 | |
| Overall Study | Treated | Placebo | 572 | |
| Overall Study | COMPLETED | Extended-release Niacin/Laropiprant | 390 | |
| Overall Study | COMPLETED | Placebo | 441 | |
| Overall Study | NOT COMPLETED | Extended-release Niacin/Laropiprant | 197 | |
| Overall Study | NOT COMPLETED | Placebo | 145 |
Source ClinicalTrials.gov
Adverse events84
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 | Extended-release Niacin/Laropiprant | 45 | 572 | 52 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 3 | 572 | 3 |
| other | Flushing | Vascular disorders | Extended-release Niacin/Laropiprant | 66 | 572 | 100 |
| other | Flushing | Vascular disorders | Placebo | 13 | 572 | 18 |
| serious | Angina unstable | Cardiac disorders | Extended-release Niacin/Laropiprant | 1 | 572 | 1 |
| serious | Angina unstable | Cardiac disorders | Placebo | 1 | 572 | 1 |
| serious | Aortic valve stenosis | Cardiac disorders | Extended-release Niacin/Laropiprant | 1 | 572 | 1 |
| serious | Aortic valve stenosis | Cardiac disorders | Placebo | 0 | 572 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | Extended-release Niacin/Laropiprant | 1 | 572 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 572 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extended-release Niacin/Laropiprant | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Extended-release Niacin/Laropiprant | 101 | 572 |
| Total, other adverse events | Placebo | 16 | 572 |
| Total, serious adverse events | Extended-release Niacin/Laropiprant | 23 | 572 |
| Total, serious adverse events | Placebo | 16 | 572 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Extended-release Niacin/Laropiprant vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01274559
GET https://conductscience.org/api/trials/v1/NCT01274559/registered?page=2