Trial · NCT00289900
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
NCT00289900, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024). Trials, record NCT00289900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00289900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
- NCT number
- NCT00289900
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,340 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Mixed Hyperlipidemia
- Interventions
- MK-0524A, Atorvastatin, Simvastatin
- First posted
- 2006-02-10
- Last updated
- 2018-08-31
- Results first posted
- 2016-01-26
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in HDL-C | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Triglycerides (TG) | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Non-HDL-C | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in LDL-C | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Apolipoprotein (Apo) B | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Apo A-I | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Total Cholesterol (TC) | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in Lipoprotein (a) (Lp[a]) | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded. |
| Secondary | Percentage Change From Baseline in C-reactive Protein (CRP) | Baseline and Week 12 | Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in HDL-C | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Triglycerides (TG) | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | MEDIAN |
| SECONDARY | Percentage Change From Baseline in Non-HDL-C | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in LDL-C | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Apolipoprotein (Apo) B | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Apo A-I | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Total Cholesterol (TC) | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Lipoprotein (a) (Lp[a]) | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | MEDIAN |
| SECONDARY | Percentage Change From Baseline in C-reactive Protein (CRP) | Baseline and Week 12 | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Percentage change | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | MK-0524B 2g/20 mg | -50.9 | 95% Confidence Interval -53.8 to -47.9 | Percentage Change | |
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | MK-0524B 2g/40mg | -53.0 | 95% Confidence Interval -55.4 to -50.7 | Percentage Change | |
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Atorvastatin 10 mg | -37.6 | 95% Confidence Interval -40.5 to -34.8 | Percentage Change | |
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Atorvastatin 20 mg | -42.4 | 95% Confidence Interval -44.5 to -40.0 | Percentage Change | |
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Atorvastatin 40 mg | -47.9 | 95% Confidence Interval -50.1 to -45.7 | Percentage Change | |
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Atorvastatin 80 mg | -48.8 | 95% Confidence Interval -51.1 to -46.6 | Percentage Change | |
| Percentage Change From Baseline in HDL-C | MK-0524B 2g/20 mg | 26.9 | 95% Confidence Interval 24.7 to 29.1 | Percentage change | |
| Percentage Change From Baseline in HDL-C | MK-0524B 2g/40mg | 26.6 | 95% Confidence Interval 24.8 to 28.4 | Percentage change | |
| Percentage Change From Baseline in HDL-C | Atorvastatin 10 mg | 7.0 | 95% Confidence Interval 4.8 to 9.1 | Percentage change | |
| Percentage Change From Baseline in HDL-C | Atorvastatin 20 mg | 5.3 | 95% Confidence Interval 3.6 to 7.0 | Percentage change |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-0524B 2g/20 mg | 297 | |
| Overall Study | STARTED | MK-0524B 2g/40mg | 436 | |
| Overall Study | STARTED | Atorvastatin 10 mg | 298 | |
| Overall Study | STARTED | Atorvastatin 20 mg | 439 | |
| Overall Study | STARTED | Atorvastatin 40 mg | 437 | |
| Overall Study | STARTED | Atorvastatin 80 mg | 433 | |
| Overall Study | Treated | MK-0524B 2g/20 mg | 297 | |
| Overall Study | Treated | MK-0524B 2g/40mg | 435 | |
| Overall Study | Treated | Atorvastatin 10 mg | 298 | |
| Overall Study | Treated | Atorvastatin 20 mg | 439 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events204
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 | Upper respiratory tract infection | Infections and infestations | MK-0524B 2g/20 mg | 4 | 297 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | MK-0524B 2g/40 mg | 13 | 435 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | Atorvastatin 10 mg | 15 | 298 | 16 |
| other | Upper respiratory tract infection | Infections and infestations | Atorvastatin 20 mg | 15 | 439 | 15 |
| other | Upper respiratory tract infection | Infections and infestations | Atorvastatin 40 mg | 18 | 437 | 19 |
| other | Upper respiratory tract infection | Infections and infestations | Atorvastatin 80 mg | 15 | 433 | 18 |
| other | Pruritus | Skin and subcutaneous tissue disorders | MK-0524B 2g/20 mg | 16 | 297 | 23 |
| other | Pruritus | Skin and subcutaneous tissue disorders | MK-0524B 2g/40 mg | 28 | 435 | 33 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Atorvastatin 10 mg | 3 | 298 | 3 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Atorvastatin 20 mg | 3 | 439 | 4 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-0524B 2g/20 mg | ||
| Total, all-cause mortality | MK-0524B 2g/40 mg | ||
| Total, all-cause mortality | Atorvastatin 10 mg | ||
| Total, all-cause mortality | Atorvastatin 20 mg | ||
| Total, all-cause mortality | Atorvastatin 40 mg | ||
| Total, all-cause mortality | Atorvastatin 80 mg | ||
| Total, other adverse events | MK-0524B 2g/20 mg | 71 | 297 |
| Total, other adverse events | MK-0524B 2g/40 mg | 136 | 435 |
| Total, other adverse events | Atorvastatin 10 mg | 25 | 298 |
| Total, other adverse events | Atorvastatin 20 mg | 27 | 439 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22305632 | 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 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.
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