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Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00289900
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : January 26, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Mixed Hyperlipidemia
Interventions Drug: MK-0524A
Drug: Atorvastatin
Drug: Simvastatin
Enrollment 2340

Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks Atorvastatin 10 mg, orally, once daily for 12 weeks Atorvastatin 20 mg, orally, once daily for 12 weeks Atorvastatin 40 mg, orally, once daily for 12 weeks Atorvastatin 80 mg, orally, once daily for 12 weeks
Period Title: Overall Study
Started 297 436 298 439 437 433
Treated 297 435 298 439 437 433
Completed 229 316 265 380 392 372
Not Completed 68 120 33 59 45 61
Reason Not Completed
Adverse Event             28             40             13             19             20             33
Lost to Follow-up             7             7             8             8             4             8
Participant had flushing             18             42             1             2             0             4
Other             0             0             0             5             1             0
Participant moved             1             0             0             1             1             1
Withdrawal by Subject             10             21             8             18             12             11
Protocol Violation             3             9             2             6             7             4
site terminated             1             0             1             0             0             0
Not treated             0             1             0             0             0             0
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg Total
Hide Arm/Group Description Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks Atorvastatin 10 mg, orally, once daily for 12 weeks Atorvastatin 20 mg, orally, once daily for 12 weeks Atorvastatin 40 mg, orally, once daily for 12 weeks Atorvastatin 80 mg, orally, once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 297 436 298 439 437 433 2340
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 297 participants 436 participants 298 participants 439 participants 437 participants 433 participants 2340 participants
54.1  (10.8) 55.0  (10.3) 53.7  (10.6) 54.8  (10.8) 55.1  (10.1) 54.7  (10.5) 54.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 436 participants 298 participants 439 participants 437 participants 433 participants 2340 participants
Female
165
  55.6%
237
  54.4%
169
  56.7%
248
  56.5%
232
  53.1%
258
  59.6%
1309
  55.9%
Male
132
  44.4%
199
  45.6%
129
  43.3%
191
  43.5%
205
  46.9%
175
  40.4%
1031
  44.1%
1.Primary Outcome
Title Percentage Change From Baseline in the LDL-C/HDL-C Ratio
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage Change
-50.9
(-53.8 to -47.9)
-53.0
(-55.4 to -50.7)
-37.6
(-40.5 to -34.8)
-42.4
(-44.5 to -40.0)
-47.9
(-50.1 to -45.7)
-48.8
(-51.1 to -46.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -13.2
Confidence Interval (2-Sided) 95%
-16.8 to -9.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.8
Confidence Interval (2-Sided) 95%
-13.8 to -7.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-8.1 to -2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-7.2 to -1.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change From Baseline in HDL-C
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
26.9
(24.7 to 29.1)
26.6
(24.8 to 28.4)
7.0
(4.8 to 9.1)
5.3
(3.6 to 7.0)
4.5
(2.8 to 6.2)
3.6
(1.9 to 5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 19.9
Confidence Interval (2-Sided) 95%
17.2 to 22.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 21.3
Confidence Interval (2-Sided) 95%
19.0 to 23.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
19.8 to 24.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 23.0
Confidence Interval (2-Sided) 95%
20.7 to 25.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change From Baseline in Triglycerides (TG)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Median (95% Confidence Interval)
Unit of Measure: Percentage change
-40.3
(-44.2 to -36.5)
-42.0
(-45.7 to -38.4)
-21.9
(-25.0 to -18.8)
-23.8
(-26.5 to -21.2)
-30.4
(-32.8 to -27.9)
-33.8
(-36.4 to -31.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -17.3
Confidence Interval (2-Sided) 95%
-21.2 to -13.3
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon’s rank sum test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -15.5
Confidence Interval (2-Sided) 95%
-19.1 to -11.9
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-13.7 to -7.0
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atorvastatin 40 mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-10.2 to -3.4
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
4.Secondary Outcome
Title Percentage Change From Baseline in Non-HDL-C
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-40.4
(-42.9 to -37.9)
-42.2
(-44.2 to -40.2)
-31.3
(-33.7 to -28.9)
-36.8
(-38.7 to -34.9)
-42.6
(-44.5 to -40.7)
-44.6
(-46.6 to -42.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-12.1 to -6.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-8.0 to -2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-2.2 to 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-0.2 to 5.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage Change From Baseline in LDL-C
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-40.4
(-43.0 to -37.7)
-42.8
(-44.9 to -40.7)
-33.6
(-36.1 to -31.0)
-39.8
(-41.8 to -37.8)
-45.6
(-47.6 to -43.6)
-47.5
(-49.5 to -45.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in least Squares Mean
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-10.2 to -3.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-5.8 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
0.0 to 5.6
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Sqaures Mean
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
2.0 to 7.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage Change From Baseline in Apolipoprotein (Apo) B
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 248 350 272 396 404 389
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-36.1
(-38.4 to -33.7)
-38.0
(-39.9 to -36.2)
-26.9
(-29.2 to -24.6)
-32.8
(-34.6 to -31.0)
-37.2
(-38.9 to -35.4)
-38.3
(-40.1 to -36.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-12.1 to -6.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.2
Confidence Interval (2-Sided) 95%
-7.7 to -2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.3 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-2.2 to 2.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage Change From Baseline in Apo A-I
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 248 350 272 396 404 389
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
10.7
(8.7 to 12.6)
8.2
(6.7 to 9.7)
1.7
(-0.2 to 3.5)
0.4
(-1.0 to 1.9)
-0.8
(-2.2 to 0.7)
-2.5
(-3.9 to -1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
6.6 to 11.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
5.8 to 9.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
7.0 to 10.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
8.7 to 12.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage Change From Baseline in Total Cholesterol (TC)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-28.1
(-30.1 to -26.2)
-30.0
(-31.5 to -28.4)
-24.6
(-26.4 to -22.7)
-29.4
(-30.9 to -27.9)
-34.2
(-35.7 to -32.7)
-36.1
(-37.6 to -34.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-6.0 to -1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.595
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.5 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
2.2 to 6.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
4.1 to 8.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage Change From Baseline in Lipoprotein (a) (Lp[a])
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 248 350 272 396 404 391
Median (95% Confidence Interval)
Unit of Measure: Percentage change
-15.2
(-19.9 to -10.6)
-14.6
(-17.9 to -11.4)
0.0
(-2.9 to 2.9)
0.0
(-3.4 to 3.4)
7.8
(4.6 to 11.1)
8.8
(5.5 to 12.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -18.8
Confidence Interval (2-Sided) 95%
-24.2 to -14.2
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -20.5
Confidence Interval (2-Sided) 95%
-25.0 to -16.6
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -23.9
Confidence Interval (2-Sided) 95%
-27.8 to -19.4
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -24.6
Confidence Interval (2-Sided) 95%
-28.6 to -20.0
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
10.Secondary Outcome
Title Percentage Change From Baseline in C-reactive Protein (CRP)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 246 351 274 397 406 396
Median (95% Confidence Interval)
Unit of Measure: Percentage change
-15.4
(-23.8 to -7.0)
-20.0
(-27.3 to -12.7)
-19.5
(-26.2 to -12.8)
-28.6
(-34.2 to -22.9)
-33.3
(-38.0 to -28.6)
-38.1
(-43.1 to -33.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-9.6 to 7.5
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
0.0 to 13.8
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
5.2 to 18.8
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-parametric ANOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 16.4
Confidence Interval (2-Sided) 95%
9.8 to 22.8
Estimation Comments Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test
11.Secondary Outcome
Title Percentage Change From Baseline in TC/HDL-C Ratio
Hide Description Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg, orally, once daily for 12 weeks
Overall Number of Participants Analyzed 255 361 280 402 410 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-41.0
(-43.2 to -38.7)
-42.3
(-44.2 to -40.5)
-28.2
(-30.4 to -26.0)
-31.5
(-33.3 to -29.8)
-36.0
(-37.7 to -34.2)
-36.7
(-38.5 to -35.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg, Atorvastatin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -12.8
Confidence Interval (2-Sided) 95%
-15.6 to -9.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.8
Confidence Interval (2-Sided) 95%
-13.2 to -8.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -6.4
Confidence Interval (2-Sided) 95%
-8.8 to -4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/40mg, Atorvastatin 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-8.0 to -3.2
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
Hide Description Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.4 1.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.3 to -0.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN
Hide Description Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.1 0.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.4 to -0.0
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN
Hide Description Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.4
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
Hide Description Participants had CK assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.1 0.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.7
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
Hide Description Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.1 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.8
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
Hide Description Participants had CK assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 701 1577
Measure Type: Number
Unit of Measure: Percentage of Participants
0.1 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value 0.1
Confidence Interval 95%
-0.1 to 0.8
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
Hide Description Participants had blood glucose levels assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 605 1343
Measure Type: Number
Unit of Measure: Percentage of Participants
0.2 0.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5625
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.9
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With New Diagnosis of Diabetes
Hide Description Participants had blood glucose levels assessed throughout the 12 week treatment period. 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.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 703 1523
Measure Type: Number
Unit of Measure: Percentage of Participants
0.9 0.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0233
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.1 to 1.7
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
Hide Description 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.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
0.1 0.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7858
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.6
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
Hide Description 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
59.6 45.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 13.7
Confidence Interval (2-Sided) 95%
9.4 to 18.0
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)
Hide Description 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
5.2 5.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.6 to 1.4
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
Hide Description 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
16.5 4.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
8.9 to 14.7
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
Hide Description 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
0.7 0.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.8 to 0.9
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE
Hide Description 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.
Time Frame up to 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.
Arm/Group Title MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled) Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Hide Arm/Group Description:
Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
Overall Number of Participants Analyzed 732 1607
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled), Atorvastatin 10, 20, 40, or 80 mg (Pooled)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4997
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.5
Estimation Comments [Not Specified]
Time Frame up to 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-0524B 2g/20 mg MK-0524B 2g/40 mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks Atorvastatin 10 mg, orally, once daily for 12 weeks Atorvastatin 20 mg, orally, once daily for 12 weeks Atorvastatin 40 mg, orally, once daily for 12 weeks Atorvastatin 80 mg, orally, once daily for 12 weeks
All-Cause Mortality
MK-0524B 2g/20 mg MK-0524B 2g/40 mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-0524B 2g/20 mg MK-0524B 2g/40 mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/297 (1.01%)      8/435 (1.84%)      3/298 (1.01%)      5/439 (1.14%)      3/437 (0.69%)      7/433 (1.62%)    
Cardiac disorders             
Arteriosclerosis coronary artery  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 1/437 (0.23%)  1 0/433 (0.00%)  0
Atrial fibrillation  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Cardio-respiratory arrest  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Coronary artery occlusion  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Myocardial infarction  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Eye disorders             
Angle closure glaucoma  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Gastrointestinal disorders             
Vomiting  1  1/297 (0.34%)  1 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
General disorders             
Adverse drug reaction  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Chest pain  1  1/297 (0.34%)  1 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 1/437 (0.23%)  1 1/433 (0.23%)  1
Device malfunction  1  1/297 (0.34%)  1 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Multi-organ failure  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Infections and infestations             
Abscess oral  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Appendicitis  1  1/297 (0.34%)  1 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Diverticulitis  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 1/437 (0.23%)  1 0/433 (0.00%)  0
Herpes zoster  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Sepsis  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 1/433 (0.23%)  1
Injury, poisoning and procedural complications             
Ankle fracture  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Concussion  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Fall  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Femur fracture  1  0/297 (0.00%)  0 0/435 (0.00%)  0 1/298 (0.34%)  1 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Multiple injuries  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Muscle strain  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  2
Skeletal injury  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Bursitis  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Muscle haemorrhage  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Glioblastoma  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 1/433 (0.23%)  1
Prostate cancer  1  0/297 (0.00%)  0 1/435 (0.23%)  1 0/298 (0.00%)  0 0/439 (0.00%)  0 0/437 (0.00%)  0 0/433 (0.00%)  0
Nervous system disorders             
Transient ischaemic attack  1  0/297 (0.00%)  0 0/435 (0.00%)  0 1/298 (0.34%)  1 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dyspnoea  1  0/297 (0.00%)  0 0/435 (0.00%)  0 0/298 (0.00%)  0 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Vascular disorders             
Arteriosclerosis  1  0/297 (0.00%)  0 0/435 (0.00%)  0 1/298 (0.34%)  1 1/439 (0.23%)  1 0/437 (0.00%)  0 0/433 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0524B 2g/20 mg MK-0524B 2g/40 mg Atorvastatin 10 mg Atorvastatin 20 mg Atorvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/297 (23.91%)      136/435 (31.26%)      25/298 (8.39%)      27/439 (6.15%)      31/437 (7.09%)      35/433 (8.08%)    
Infections and infestations             
Upper respiratory tract infection  1  4/297 (1.35%)  4 13/435 (2.99%)  14 15/298 (5.03%)  16 15/439 (3.42%)  15 18/437 (4.12%)  19 15/433 (3.46%)  18
Skin and subcutaneous tissue disorders             
Pruritus  1  16/297 (5.39%)  23 28/435 (6.44%)  33 3/298 (1.01%)  3 3/439 (0.68%)  4 2/437 (0.46%)  2 1/433 (0.23%)  1
Vascular disorders             
Flushing  1  57/297 (19.19%)  67 102/435 (23.45%)  120 7/298 (2.35%)  7 11/439 (2.51%)  13 12/437 (2.75%)  12 19/433 (4.39%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289900     History of Changes
Other Study ID Numbers: 0524B-024
MK-0524B-024 ( Other Identifier: Merck Study Number )
2005_103
First Submitted: February 7, 2006
First Posted: February 10, 2006
Results First Submitted: December 17, 2015
Results First Posted: January 26, 2016
Last Update Posted: August 31, 2018