Trial · NCT00384293
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
NCT00384293, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2009-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED). Trials, record NCT00384293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00384293
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
- NCT number
- NCT00384293
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 937 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypercholesterolemia, Familial
- Interventions
- Comparator: niacin (+) laropiprant (MK0524A), Comparator: placebo
- First posted
- 2006-10-06
- Last updated
- 2015-09-30
- Results first posted
- 2009-09-02
- Limitations and caveats
After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not performed.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Carotid Intima Media Thickness | after 96 weeks of postrandomization treatment | change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery. |
| Secondary | Change in Lipid Profile | after 96 weeks of postrandomization treatment |
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 in Mean Carotid Intima Media Thickness | after 96 weeks of postrandomization treatment | study prematurely terminated, no efficacy analyses were performed | ||
| SECONDARY | Change in Lipid Profile | after 96 weeks of postrandomization treatment | study prematurely terminated, no efficacy analyses were performed |
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 flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| MK0524A Active Run-In, Pre-randomization | STARTED | MK0524A Active Run-In Period | 937 | |
| MK0524A Active Run-In, Pre-randomization | STARTED | MK0524A, 2 g (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | STARTED | Placebo (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | Entered Active run-in, MK0524A 1 g | MK0524A Active Run-In Period | 937 | |
| MK0524A Active Run-In, Pre-randomization | Entered Active run-in, MK0524A 1 g | MK0524A, 2 g (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | Entered Active run-in, MK0524A 1 g | Placebo (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | MK0524A Dose Increased to 2 g | MK0524A Active Run-In Period | 813 | |
| MK0524A Active Run-In, Pre-randomization | MK0524A Dose Increased to 2 g | MK0524A, 2 g (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | MK0524A Dose Increased to 2 g | Placebo (Postrandomization Period) | 0 | |
| MK0524A Active Run-In, Pre-randomization | COMPLETED | MK0524A Active Run-In Period | 433 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events138
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 | Diarrhoea | Gastrointestinal disorders | MK0524A Active Run-In Period | 20 | 937 | |
| other | Diarrhoea | Gastrointestinal disorders | MK0524A, 2 g (Postrandomization Period) | 8 | 214 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Postrandomization Period) | 4 | 218 | |
| other | Nausea | Gastrointestinal disorders | MK0524A Active Run-In Period | 24 | 937 | |
| other | Nausea | Gastrointestinal disorders | MK0524A, 2 g (Postrandomization Period) | 5 | 214 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Postrandomization Period) | 0 | 218 | |
| other | Vomiting | Gastrointestinal disorders | MK0524A Active Run-In Period | 0 | 937 | |
| other | Vomiting | Gastrointestinal disorders | MK0524A, 2 g (Postrandomization Period) | 5 | 214 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (Postrandomization Period) | 0 | 218 | |
| other | Fatigue | General disorders | MK0524A Active Run-In Period | 0 | 937 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK0524A Active Run-In Period | ||
| Total, all-cause mortality | MK0524A, 2 g (Postrandomization Period) | ||
| Total, all-cause mortality | Placebo (Postrandomization Period) | ||
| Total, other adverse events | MK0524A Active Run-In Period | 395 | |
| Total, other adverse events | MK0524A, 2 g (Postrandomization Period) | 74 | |
| Total, other adverse events | Placebo (Postrandomization Period) | 54 | |
| Total, serious adverse events | MK0524A Active Run-In Period | 10 | |
| Total, serious adverse events | MK0524A, 2 g (Postrandomization Period) | 5 | |
| Total, serious adverse events | Placebo (Postrandomization Period) | 8 |
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 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/NCT00384293
GET https://conductscience.org/api/trials/v1/NCT00384293/flow?page=2