Trial · NCT00479882
MK-0524B Lipid Study (MK-0524B-063)
NCT00479882, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK-0524B Lipid Study (MK-0524B-063). Trials, record NCT00479882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00479882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-0524B Lipid Study (MK-0524B-063)
- NCT number
- NCT00479882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,414 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- Comparator: simvastatin, MK-0524A, Placebo, MK-0524B
- First posted
- 2007-05-28
- Last updated
- 2019-02-06
- Results first posted
- 2016-04-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) | Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded. |
| Secondary | Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) | Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded. |
| Secondary | Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively. |
| Secondary | Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively. |
| Secondary | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively. |
| Secondary | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively. |
| Secondary | Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome. |
| Secondary | Percentage of Participants With New Diagnosis of Diabetes | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities \[MedDRA\] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults. |
| Secondary | Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication. |
| Secondary | Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 Low-density Lipoprotein Cholesterol (LDL-C) | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) | Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence. | Percentage Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) | Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence. | Percentage Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With New Diagnosis of Diabetes | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event | up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III) | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group120
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 Low-density Lipoprotein Cholesterol (LDL-C) | MK-0524B 1.8g/20mg | -44.6 | 95% Confidence Interval -45.3 to -43.8 | Percentage Change | |
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | MK-0524A 2g+Simvastatin 20mg | -46.9 | 95% Confidence Interval -47.7 to -46.2 | Percentage Change | |
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | MK-0524B 1.8g/40mg | -48.9 | 95% Confidence Interval -49.7 to -48.2 | Percentage Change | |
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | MK-0524A 2g+Simvastatin 40mg | -50.4 | 95% Confidence Interval -51.1 to -49.7 | Percentage Change | |
| Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | MK-0524B 1.8g/20mg | 27.4 | 95% Confidence Interval 26.5 to 28.2 | Percentage Change | |
| Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | MK-0524A 2g+Simvastatin 20mg | 27.6 | 95% Confidence Interval 26.7 to 28.4 | Percentage Change | |
| Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | MK-0524B 1.8g/40mg | 27.7 | 95% Confidence Interval 26.9 to 28.4 | Percentage Change | |
| Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | MK-0524A 2g+Simvastatin 40mg | 28.5 | 95% Confidence Interval 27.8 to 29.2 | Percentage Change | |
| Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | Sequence 1: MK-0524B 1.8g/20mg | 0.3 | Percentage of Participants | ||
| Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | Sequence 2: MK-0524A 2g+Simvastatin 20mg | 0.5 | Percentage of Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Precrossover: Periods I/II (Weeks 1-12) | STARTED | Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg | 610 | |
| Precrossover: Periods I/II (Weeks 1-12) | STARTED | Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg | 602 | |
| Precrossover: Periods I/II (Weeks 1-12) | STARTED | Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg | 597 | |
| Precrossover: Periods I/II (Weeks 1-12) | STARTED | Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg | 605 | |
| Precrossover: Periods I/II (Weeks 1-12) | COMPLETED | Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg | 472 | |
| Precrossover: Periods I/II (Weeks 1-12) | COMPLETED | Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg | 440 | |
| Precrossover: Periods I/II (Weeks 1-12) | COMPLETED | Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg | 440 | |
| Precrossover: Periods I/II (Weeks 1-12) | COMPLETED | Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg | 465 | |
| Precrossover: Periods I/II (Weeks 1-12) | NOT COMPLETED | Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg | 138 | |
| Precrossover: Periods I/II (Weeks 1-12) | NOT COMPLETED | Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg | 162 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events384
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 | Sequence 1: MK-0524B 1.8g/20mg | 28 | 610 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 2: MK-0524A 2g+Simvastatin 20mg | 33 | 602 | 41 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 1: MK-0524A 2g+Simvastatin 20mg | 10 | 472 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 2: MK-0524B 1.8g/20mg | 15 | 440 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 3: MK-0524B 1.8g/40mg | 27 | 597 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 4: MK-0524A 2g+Simvastatin 40mg | 37 | 605 | 39 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 3: MK-0524A 2g+Simvastatin 40mg | 8 | 440 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Sequence 4: MK-0524B 1.8g/40mg | 13 | 465 | 15 |
| other | Headache | Nervous system disorders | Sequence 1: MK-0524B 1.8g/20mg | 18 | 610 | 19 |
| other | Headache | Nervous system disorders | Sequence 2: MK-0524A 2g+Simvastatin 20mg | 32 | 602 | 35 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequence 1: MK-0524B 1.8g/20mg | ||
| Total, all-cause mortality | Sequence 2: MK-0524A 2g+Simvastatin 20mg | ||
| Total, all-cause mortality | Sequence 1: MK-0524A 2g+Simvastatin 20mg | ||
| Total, all-cause mortality | Sequence 2: MK-0524B 1.8g/20mg | ||
| Total, all-cause mortality | Sequence 3: MK-0524B 1.8g/40mg | ||
| Total, all-cause mortality | Sequence 4: MK-0524A 2g+Simvastatin 40mg | ||
| Total, all-cause mortality | Sequence 3: MK-0524A 2g+Simvastatin 40mg | ||
| Total, all-cause mortality | Sequence 4: MK-0524B 1.8g/40mg | ||
| Total, other adverse events | Sequence 1: MK-0524B 1.8g/20mg | 225 | 610 |
| Total, other adverse events | Sequence 2: MK-0524A 2g+Simvastatin 20mg | 227 | 602 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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.
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