Trial · NCT00536510
Effect of MK0524A on Cholesterol Levels (0524A-048)
NCT00536510, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of MK0524A on Cholesterol Levels (0524A-048). Trials, record NCT00536510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00536510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of MK0524A on Cholesterol Levels (0524A-048)
- NCT number
- NCT00536510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 646 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypercholesterolemia, Hyperlipidemia
- Interventions
- laropiprant/niacin (MK0524A), Comparator: placebo
- First posted
- 2007-09-27
- Last updated
- 2015-09-02
- Results first posted
- 2009-05-13
Source ClinicalTrials.gov
Registered outcomes2
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) After 12 Weeks | 12 weeks | Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100 |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | 12 weeks | Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100 |
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 | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks | 12 weeks | Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | 12 weeks | Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12. | Percent Change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
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) After 12 Weeks | MK0524A 2 g | -10.3 | 95% Confidence Interval -13.2 to -7.4 | Percent Change | |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks | Placebo | 4.4 | 95% Confidence Interval 1.7 to 7.2 | Percent Change | |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | MK0524A 2 g | 18.6 | 95% Confidence Interval 16.1 to 21.1 | Percent Change | |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | Placebo | 2.6 | 95% Confidence Interval 0.3 to 5.0 | Percent Change |
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 | MK0524A 2 g | 322 | |
| Overall Study | STARTED | Placebo | 324 | |
| Overall Study | COMPLETED | MK0524A 2 g | 240 | |
| Overall Study | COMPLETED | Placebo | 295 | |
| Overall Study | NOT COMPLETED | MK0524A 2 g | 82 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events30
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 | Nausea | Gastrointestinal disorders | MK0524A 2 g | 10 | 321 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 323 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | MK0524A 2 g | 7 | 321 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 10 | 323 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | MK0524A 2 g | 26 | 321 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 3 | 323 | |
| other | Rash | Skin and subcutaneous tissue disorders | MK0524A 2 g | 13 | 321 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 2 | 323 | |
| other | Flushing | Vascular disorders | MK0524A 2 g | 37 | 321 | |
| other | Flushing | Vascular disorders | Placebo | 8 | 323 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK0524A 2 g | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MK0524A 2 g | 123 | 321 |
| Total, other adverse events | Placebo | 54 | 323 |
| Total, serious adverse events | MK0524A 2 g | 3 | 321 |
| Total, serious adverse events | Placebo | 2 | 323 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21291812 | RESULT |
Source PubMed
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 |
|---|
| MK0524A 2 g 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/NCT00536510
GET https://conductscience.org/api/trials/v1/NCT00536510/events?page=2