Trial · NCT01294683
A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
NCT01294683, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118). Trials, record NCT01294683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01294683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
- NCT number
- NCT01294683
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 977 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Hypercholesterolemia, Dyslipidemia
- Interventions
- Simvastatin, Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM), Extended Release (ER) niacin/laropiprant (N/LRPT), Placebo
- First posted
- 2011-02-11
- Last updated
- 2018-08-16
- Other registries' IDs
- eudract:2010-023939-42
- Results first posted
- 2016-12-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 (Week 12 for Period II and Week 20 for Period III) | Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. |
| Secondary | 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 were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. |
| 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 Periods I/II and 8 weeks in Period III) | Participants had AST and ALT levels assessed during Period I (4 weeks ) and 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 UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. |
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | up 20 weeks (12 weeks in Periods 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 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. |
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | up 20 weeks (12 weeks in Periods 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 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs 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 Periods I/II and 8 weeks in Period III) | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was \>=10 x ULN were recorded. The UNLs 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 Periods I/II and 8 weeks in Period III) | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was \>=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. |
| Secondary | Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE) | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury. |
| Secondary | Percentage of Participants With New Onset of Diabetes | up 20 weeks (12 weeks in Periods 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 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 a Confirmed Adjudicated Cardiovascular Event | up 20 weeks (12 weeks in Periods 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 a cardiovascular events were recorded. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 (Week 12 for Period II and Week 20 for Period III) | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | ||
| SECONDARY | 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) | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | ||
| 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 Periods I/II and 8 weeks in Period III) | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE) | up 20 weeks (12 weeks in Periods 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 followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With New Onset of Diabetes | up 20 weeks (12 weeks in Periods 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 followed 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 Periods 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 followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 2g/40g | 0.4 | 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 40 mg | 0.6 | 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 1: MK-0524A 2g + Simvastatin 40 mg | 1.3 | 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-0524B 2g/40g | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Sequence 1: MK-0524B 2g/40g | 0.2 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 0.4 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | 0.9 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Sequence 2: MK-0524B 2g/40g | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Sequence 1: MK-0524B 2g/40g | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 0.0 | Percentage of Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Precrossover (Periods I/II) | STARTED | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | 489 | |
| Precrossover (Periods I/II) | STARTED | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | 488 | |
| Precrossover (Periods I/II) | Treated | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | 486 | |
| Precrossover (Periods I/II) | Treated | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | 486 | |
| Precrossover (Periods I/II) | COMPLETED | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | 232 | |
| Precrossover (Periods I/II) | COMPLETED | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | 222 | |
| Precrossover (Periods I/II) | NOT COMPLETED | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | 257 | |
| Precrossover (Periods I/II) | NOT COMPLETED | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | 266 | |
| Post Crossover (Period III) | STARTED | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | 232 | |
| Post Crossover (Period III) | STARTED | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | 222 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events124
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 | Pruritus | Skin and subcutaneous tissue disorders | Sequence 1: MK-0524B 2g/40g | 42 | 486 | 51 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 33 | 486 | 38 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | 0 | 230 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Sequence 2: MK-0524B 2g/40g | 0 | 220 | 0 |
| other | Flushing | Vascular disorders | Sequence 1: MK-0524B 2g/40g | 88 | 486 | 104 |
| other | Flushing | Vascular disorders | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 75 | 486 | 86 |
| other | Flushing | Vascular disorders | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | 0 | 230 | 0 |
| other | Flushing | Vascular disorders | Sequence 2: MK-0524B 2g/40g | 0 | 220 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Sequence 1: MK-0524B 2g/40g | 0 | 486 | |
| serious | Coronary artery disease | Cardiac disorders | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 0 | 486 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequence 1: MK-0524B 2g/40g | ||
| Total, all-cause mortality | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | ||
| Total, all-cause mortality | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | ||
| Total, all-cause mortality | Sequence 2: MK-0524B 2g/40g | ||
| Total, other adverse events | Sequence 1: MK-0524B 2g/40g | 110 | 486 |
| Total, other adverse events | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 98 | 486 |
| Total, other adverse events | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | 0 | 230 |
| Total, other adverse events | Sequence 2: MK-0524B 2g/40g | 0 | 220 |
| Total, serious adverse events | Sequence 1: MK-0524B 2g/40g | 6 | 486 |
| Total, serious adverse events | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | 9 | 486 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT01294683
GET https://conductscience.org/api/trials/v1/NCT01294683/results?page=2