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MK-0524B Lipid Study (MK-0524B-063)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00479882
Collaborator
(none)
2,414
Enrollment
4
Arms
12.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2414 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, "Crossover" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK-0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia
Actual Study Start Date :
Jun 15, 2007
Actual Primary Completion Date :
Jun 16, 2008
Actual Study Completion Date :
Jun 16, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg

After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.

Drug: Comparator: simvastatin
Other Names:
  • Zocor®
  • MK0733

    • Drug: MK-0524A
    Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet

    Drug: Placebo

    Drug: MK-0524B
    Experimental: Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg

    After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.

    Drug: Comparator: simvastatin
    Other Names:
  • Zocor®
  • MK0733

    • Drug: MK-0524A
    Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet

    Drug: Placebo

    Drug: MK-0524B
    Experimental: Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg

    After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.

    Drug: Comparator: simvastatin
    Other Names:
  • Zocor®
  • MK0733

    • Drug: MK-0524A
    Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet

    Drug: Placebo

    Drug: MK-0524B
    Experimental: Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

    After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.

    Drug: Comparator: simvastatin
    Other Names:
  • Zocor®
  • MK0733

    • Drug: MK-0524A
    Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet

    Drug: Placebo

    Drug: MK-0524B

    Outcome Measures

    Primary Outcome Measures

    1. Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)]

      Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.

    Secondary Outcome Measures

    1. Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)]

      Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.

    2. Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.

    3. Percentage of Participants With Creatine Kinase (CK) >=10 x ULN [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.

    4. Percentage of Participants With CK >=10 x ULN With Muscle Symptoms [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.

    5. Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.

    6. Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.

    7. Percentage of Participants With New Diagnosis of Diabetes [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.

    8. Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.

    9. Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event [up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)]

      Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded

    10. Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE) [up 20 weeks (12 weeks in Period 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.

    11. Percentage of Participants Who Experience at Least 1 Laboratory AE [up 20 weeks (12 weeks in Period 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test

    12. Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE [up 20 weeks (12 weeks in Period 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. 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.

    13. Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE [up 20 weeks (12 weeks in Period 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. 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.

    14. Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE [up 20 weeks (12 weeks in Period 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. Non-serious 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.

    15. Percentage Change From Baseline in LDL-C at Week 4 [Baseline (Day1 of Period I) and Week 4]

      Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.

    16. Percentage Change From Baseline in HDL-C at Week 4 [Baseline (Day1 of Period I) and Week 4]

      Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit

    • meets one of the following triglyceride (TG) criteria:

    1. is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout

    2. is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening

    Exclusion Criteria:

    • is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin

    • is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up

    • has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1

    • has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00479882
    Other Study ID Numbers:
    • 0524B-063
    • MK-0524B-063
    • 2007_504
    First Posted:
    May 28, 2007
    Last Update Posted:
    Feb 6, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Dyslipidemias
    Simvastatin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants completed a 6-8 week washout then completed a 2-week placebo run-in prior to the start of active treatment. Includes 6 participants who had an adverse event that began during the placebo run-in but did not lead to discontinuation until after randomization in Period I or II.
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
    Arm/Group Description After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks. After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks. After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
    Period Title: Precrossover: Periods I/II (Weeks 1-12)
    STARTED 610 602 597 605
    COMPLETED 472 440 440 465
    NOT COMPLETED 138 162 157 140
    Period Title: Precrossover: Periods I/II (Weeks 1-12)
    STARTED 472 440 440 465
    COMPLETED 447 419 420 447
    NOT COMPLETED 25 21 20 18

    Baseline Characteristics

    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg Total
    Arm/Group Description After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks. After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks. After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks. Total of all reporting groups
    Overall Participants 610 602 597 605 2414
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    491
    80.5%
    470
    78.1%
    468
    78.4%
    477
    78.8%
    1906
    79%
    >=65 years
    119
    19.5%
    132
    21.9%
    129
    21.6%
    128
    21.2%
    508
    21%
    Sex: Female, Male (Count of Participants)
    Female
    325
    53.3%
    334
    55.5%
    313
    52.4%
    316
    52.2%
    1288
    53.4%
    Male
    285
    46.7%
    268
    44.5%
    284
    47.6%
    289
    47.8%
    1126
    46.6%

    Outcome Measures

    1. Primary Outcome
    Title Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
    Description Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
    Arm/Group Title MK-0524B 1.8g/20mg MK-0524A 2g+Simvastatin 20mg MK-0524B 1.8g/40mg MK-0524A 2g+Simvastatin 40mg
    Arm/Group Description Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence. Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence. Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence. Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
    Measure Participants 844 844 843 843
    Least Squares Mean (95% Confidence Interval) [Percentage Change]
    -44.6
    -46.9
    -48.9
    -50.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Least squares mean
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    1.3 to 3.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Least Squares Mean
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    0.4 to 2.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
    Description Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
    Arm/Group Title MK-0524B 1.8g/20mg MK-0524A 2g+Simvastatin 20mg MK-0524B 1.8g/40mg MK-0524A 2g+Simvastatin 40mg
    Arm/Group Description Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence. Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence. Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence. Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
    Measure Participants 845 845 845 845
    Least Squares Mean (95% Confidence Interval) [Percentage Change]
    27.4
    27.6
    27.7
    28.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Least Squares Mean
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.4 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Least Squares Mean
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.9 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. 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)
    Description Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 588 580 469 437 568 592 438 464
    Number [Percentage of Participants]
    0.3
    0%
    0.5
    0.1%
    0.6
    0.1%
    0.9
    0.1%
    0.7
    0%
    1.0
    NaN
    0.5
    NaN
    0.2
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.685
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.8 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.753
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.8 to 1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    4. Secondary Outcome
    Title Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
    Description Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 588 580 469 437 568 592 438 464
    Number [Percentage of Participants]
    0.0
    0%
    0.0
    0%
    0.4
    0.1%
    0.0
    0%
    0.4
    0%
    0.2
    NaN
    0.0
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.5 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.617
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    5. Secondary Outcome
    Title Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
    Description Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 588 580 469 437 568 592 438 464
    Number [Percentage of Participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    NaN
    0.0
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    6. Secondary Outcome
    Title Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
    Description Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 588 580 469 437 568 592 438 464
    Number [Percentage of Participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    NaN
    0.0
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    7. Secondary Outcome
    Title Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
    Description Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 484 473 468 483 365 343 345 372
    Number [Percentage of Participants]
    0.0
    0%
    0.2
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    NaN
    0.0
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.497
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Participants With New Diagnosis of Diabetes
    Description 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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 554 551 427 404 545 545 404 422
    Number [Percentage of Participants]
    0.4
    0.1%
    0.7
    0.1%
    0.5
    0.1%
    0.7
    0.1%
    0.6
    0%
    0.4
    NaN
    0.7
    NaN
    0.5
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.449
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.4 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Period I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.685
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.8 to 1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    9. Secondary Outcome
    Title Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline
    Description Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 56 51 45 36 52 60 36 43
    Number [Percentage of Participants]
    1.8
    0.3%
    15.7
    2.6%
    4.4
    0.7%
    8.3
    1.4%
    3.8
    0.2%
    8.3
    NaN
    8.3
    NaN
    11.6
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.020
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.4 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.452
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.9 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    10. Secondary Outcome
    Title Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
    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 as cardiovascular events were recorded
    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    0.0
    0%
    0.0
    0%
    0.2
    0%
    0.0
    0%
    0.2
    0%
    0.0
    NaN
    0.2
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.7 to 1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Method
    11. Secondary Outcome
    Title Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
    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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    67.5
    11.1%
    68.9
    11.4%
    35.6
    6%
    37.5
    6.2%
    67.5
    2.8%
    67.4
    NaN
    32.3
    NaN
    35.1
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -6.6 to 3.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -8.1 to 4.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -5.2 to 5.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -8.9 to 3.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    12. Secondary Outcome
    Title Percentage of Participants Who Experience at Least 1 Laboratory AE
    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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    3.9
    0.6%
    4.2
    0.7%
    5.9
    1%
    3.6
    0.6%
    6.2
    0.3%
    4.6
    NaN
    5.9
    NaN
    3.9
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -2.5 to 2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    -0.5 to 5.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    -1.0 to 4.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524A 2g+Simvastatin 40mg, Sequence 4: MK-0524B 1.8g/40mg
    Comments Period III
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -0.8 to 5.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    13. Secondary Outcome
    Title Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
    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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    15.9
    2.6%
    15.9
    2.6%
    1.9
    0.3%
    2.7
    0.4%
    16.4
    0.7%
    14.4
    NaN
    2.5
    NaN
    1.5
    NaN
    14. Secondary Outcome
    Title Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
    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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    0.0
    0%
    0.7
    0.1%
    0.6
    0.1%
    0.2
    0%
    0.7
    0%
    0.8
    NaN
    0.5
    NaN
    0.2
    NaN
    15. Secondary Outcome
    Title Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE
    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. Non-serious 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 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    Measure Participants 610 602 472 440 597 605 440 465
    Number [Percentage of Participants]
    0.2
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.2
    NaN
    0.0
    NaN
    0.0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sequence 3: MK-0524B 1.8g/40mg, Sequence 4: MK-0524A 2g+Simvastatin 40mg
    Comments Periods I/II
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Wilson's Score Method
    16. Secondary Outcome
    Title Percentage Change From Baseline in LDL-C at Week 4
    Description Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
    Time Frame Baseline (Day1 of Period I) and Week 4

    Outcome Measure Data

    Analysis Population Description
    Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
    Arm/Group Title MK-0524B 0.9g/10mg MK-0524A 1g+Simvastatin 10mg MK-0524B 0.9 g/40 mg MK-0524A 1 g + Simvastatin 40 mg
    Arm/Group Description Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
    Measure Participants 582 574 556 581
    Least Squares Mean (95% Confidence Interval) [Percentage Change]
    -34.8
    -35.8
    -42.2
    -45.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.341
    Comments
    Method ANOVA
    Comments Factors for treatment, country and gender
    Method of Estimation Estimation Parameter Difference in Least Squares Means
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    -1.1 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method ANOVA
    Comments Factors for treatment, country and gender.
    Method of Estimation Estimation Parameter Difference in Least Squares Means
    Estimated Value 3.7
    Confidence Interval (2-Sided) 95%
    1.2 to 6.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Percentage Change From Baseline in HDL-C at Week 4
    Description Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
    Time Frame Baseline (Day1 of Period I) and Week 4

    Outcome Measure Data

    Analysis Population Description
    Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
    Arm/Group Title MK-0524B 0.9g/10mg MK-0524A 1g+Simvastatin 10mg MK-0524B 0.9 g/40 mg MK-0524A 1 g + Simvastatin 40 mg
    Arm/Group Description Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence. Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
    Measure Participants 582 575 555 583
    Least Squares Mean (95% Confidence Interval) [Percentage Change]
    18.3
    18.7
    19.8
    19.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/20mg, MK-0524A 2g+Simvastatin 20mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.690
    Comments
    Method ANOVA
    Comments Factors for treatment, country and gender
    Method of Estimation Estimation Parameter Difference in Least Squares Mean
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -2.3 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MK-0524B 1.8g/40mg, MK-0524A 2g+Simvastatin 40mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.879
    Comments
    Method ANOVA
    Comments Factors for treatment, country and gender
    Method of Estimation Estimation Parameter Difference in Least Squares Means
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -1.9 to 2.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
    Adverse Event Reporting Description All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
    Arm/Group Title Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Arm/Group Description Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III Participants who received MK-0524B 1.8g/20mg during Periods III Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III Participants who received MK-0524B 1.8g/40mg during Periods III
    All Cause Mortality
    Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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 / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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 3/610 (0.5%) 6/602 (1%) 4/472 (0.8%) 2/440 (0.5%) 12/597 (2%) 9/605 (1.5%) 4/440 (0.9%) 3/465 (0.6%)
    Cardiac disorders
    Atrial fibrillation 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 1/465 (0.2%) 1
    Coronary artery disease 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Myocarditis 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Sick sinus syndrome 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Gastrointestinal disorders
    Colitis 0/610 (0%) 0 0/602 (0%) 0 1/472 (0.2%) 1 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Haemorrhoids 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 1/465 (0.2%) 1
    Inguinal hernia 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 1/440 (0.2%) 1 0/465 (0%) 0
    Nausea 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Umbilical hernia 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Vomiting 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    General disorders
    Chest pain 1/610 (0.2%) 1 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Hepatobiliary disorders
    Bile duct stone 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Cholecystitis acute 1/610 (0.2%) 1 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Cholecystitis chronic 0/610 (0%) 0 0/602 (0%) 0 1/472 (0.2%) 1 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Infections and infestations
    Appendicitis 0/610 (0%) 0 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Cystitis 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Viral infection 0/610 (0%) 0 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Injury, poisoning and procedural complications
    Device migration 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Face injury 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Head injury 0/610 (0%) 0 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Lower limb fracture 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Skin laceration 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 1/440 (0.2%) 1 0/465 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 2/440 (0.5%) 2 0/465 (0%) 0
    Fluid retention 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Hypoglycaemia 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/610 (0%) 0 0/602 (0%) 0 1/472 (0.2%) 1 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Rotator cuff syndrome 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 1/440 (0.2%) 1 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Lung neoplasm malignant 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Meningioma 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Pharyngeal neoplasm benign 0/610 (0%) 0 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Prostate cancer 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Rectal cancer 1/610 (0.2%) 1 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Squamous cell carcinoma 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 1/465 (0.2%) 1
    Nervous system disorders
    Cerebrovascular accident 0/610 (0%) 0 0/602 (0%) 0 1/472 (0.2%) 1 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Encephalopathy 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Syncope vasovagal 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 1/440 (0.2%) 1 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Reproductive system and breast disorders
    Menorrhagia 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Prostatitis 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Choking 0/610 (0%) 0 1/602 (0.2%) 1 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Skin and subcutaneous tissue disorders
    Drug eruption 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 1/597 (0.2%) 1 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Erythema nodosum 0/610 (0%) 0 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 1/605 (0.2%) 1 0/440 (0%) 0 0/465 (0%) 0
    Vascular disorders
    Hypotension 1/610 (0.2%) 1 0/602 (0%) 0 0/472 (0%) 0 0/440 (0%) 0 0/597 (0%) 0 0/605 (0%) 0 0/440 (0%) 0 0/465 (0%) 0
    Other (Not Including Serious) Adverse Events
    Sequence 1: MK-0524B 1.8g/20mg Sequence 2: MK-0524A 2g+Simvastatin 20mg Sequence 1: MK-0524A 2g+Simvastatin 20mg Sequence 2: MK-0524B 1.8g/20mg Sequence 3: MK-0524B 1.8g/40mg Sequence 4: MK-0524A 2g+Simvastatin 40mg Sequence 3: MK-0524A 2g+Simvastatin 40mg Sequence 4: MK-0524B 1.8g/40mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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 225/610 (36.9%) 227/602 (37.7%) 40/472 (8.5%) 48/440 (10.9%) 222/597 (37.2%) 237/605 (39.2%) 31/440 (7%) 45/465 (9.7%)
    Gastrointestinal disorders
    Diarrhoea 28/610 (4.6%) 32 33/602 (5.5%) 41 10/472 (2.1%) 10 15/440 (3.4%) 17 27/597 (4.5%) 29 37/605 (6.1%) 39 8/440 (1.8%) 8 13/465 (2.8%) 15
    Nervous system disorders
    Headache 18/610 (3%) 19 32/602 (5.3%) 35 5/472 (1.1%) 6 9/440 (2%) 10 24/597 (4%) 25 28/605 (4.6%) 31 6/440 (1.4%) 8 8/465 (1.7%) 9
    Skin and subcutaneous tissue disorders
    Pruritus 67/610 (11%) 79 72/602 (12%) 84 9/472 (1.9%) 11 15/440 (3.4%) 17 50/597 (8.4%) 54 75/605 (12.4%) 93 5/440 (1.1%) 5 7/465 (1.5%) 7
    Vascular disorders
    Flushing 155/610 (25.4%) 189 132/602 (21.9%) 166 23/472 (4.9%) 34 15/440 (3.4%) 20 162/597 (27.1%) 189 151/605 (25%) 179 14/440 (3.2%) 15 19/465 (4.1%) 23

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00479882
    Other Study ID Numbers:
    • 0524B-063
    • MK-0524B-063
    • 2007_504
    First Posted:
    May 28, 2007
    Last Update Posted:
    Feb 6, 2019
    Last Verified:
    Jan 1, 2019