Trial · NCT00479388
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
NCT00479388, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067). Trials, record NCT00479388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00479388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
- NCT number
- NCT00479388
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,216 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- Comparator: simvastatin, niacin (+) laropiprant, Comparator: atorvastatin calcium
- First posted
- 2007-05-28
- Last updated
- 2015-03-10
- Results first posted
- 2009-07-31
Source ClinicalTrials.gov
Registered outcomes3
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 at Week 12 | Baseline and 12 Weeks | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 | Baseline and 12 Weeks | |
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | Baseline and 12 Weeks |
Source ClinicalTrials.gov
Outcomes3
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 at Week 12 | Baseline and 12 Weeks | Full Analysis Set | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 | Baseline and 12 Weeks | Full Analysis Set | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides at Week 12 | Baseline and 12 Weeks | Full Analysis Set With at Least one Post-Titration Visit Measurement | Percent | MEDIAN |
Source ClinicalTrials.gov
Results by group6
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 at Week 12 | ER Niacin/Laropiprant + Run-in Statin | -10.0 | 95% Confidence Interval -12.6 to -7.4 | Percent | |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 | Run-in Statin Dose Doubled | -5.5 | 95% Confidence Interval -7.4 to -3.5 | Percent | |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 | ER Niacin/Laropiprant + Run-in Statin | 15.8 | 95% Confidence Interval 13.8 to 17.8 | Percent | |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 | Run-in Statin Dose Doubled | 0.2 | 95% Confidence Interval -1.1 to 1.4 | Percent | |
| Percent Change From Baseline in Triglycerides at Week 12 | ER Niacin/Laropiprant + Run-in Statin | -17.6 | 95% Confidence Interval -21.0 to -14.2 | Percent | |
| Percent Change From Baseline in Triglycerides at Week 12 | Run-in Statin Dose Doubled | -4.0 | 95% Confidence Interval -7.2 to -0.9 | Percent |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ER Niacin/Laropiprant + Run-in Statin | 606 | |
| Overall Study | STARTED | Run-in Statin Dose Doubled | 610 | |
| Overall Study | COMPLETED | ER Niacin/Laropiprant + Run-in Statin | 474 | |
| Overall Study | COMPLETED | Run-in Statin Dose Doubled | 537 | |
| Overall Study | NOT COMPLETED | ER Niacin/Laropiprant + Run-in Statin | 132 | |
| Overall Study | NOT COMPLETED | Run-in Statin Dose Doubled | 73 |
Source ClinicalTrials.gov
Adverse events428
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 | Anaemia | Blood and lymphatic system disorders | ER Niacin/Laropiprant + Run-in Statin | 0 | 602 | |
| other | Anaemia | Blood and lymphatic system disorders | Run-in Statin Dose Doubled | 1 | 609 | |
| other | Neutropenia | Blood and lymphatic system disorders | ER Niacin/Laropiprant + Run-in Statin | 0 | 602 | |
| other | Neutropenia | Blood and lymphatic system disorders | Run-in Statin Dose Doubled | 2 | 609 | |
| other | Splenomegaly | Blood and lymphatic system disorders | ER Niacin/Laropiprant + Run-in Statin | 0 | 602 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Run-in Statin Dose Doubled | 1 | 609 | |
| other | Angina pectoris | Cardiac disorders | ER Niacin/Laropiprant + Run-in Statin | 1 | 602 | |
| other | Angina pectoris | Cardiac disorders | Run-in Statin Dose Doubled | 1 | 609 | |
| other | Arrhythmia | Cardiac disorders | ER Niacin/Laropiprant + Run-in Statin | 0 | 602 | |
| other | Arrhythmia | Cardiac disorders | Run-in Statin Dose Doubled | 1 | 609 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ER Niacin/Laropiprant + Run-in Statin | ||
| Total, all-cause mortality | Run-in Statin Dose Doubled | ||
| Total, other adverse events | ER Niacin/Laropiprant + Run-in Statin | 249 | |
| Total, other adverse events | Run-in Statin Dose Doubled | 172 | |
| Total, serious adverse events | ER Niacin/Laropiprant + Run-in Statin | 14 | |
| Total, serious adverse events | Run-in Statin Dose Doubled | 8 |
Source ClinicalTrials.gov
Papers3
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/NCT00479388
GET https://conductscience.org/api/trials/v1/NCT00479388/events?page=2