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

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ClinicalTrials.gov Identifier: NCT00289900
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : January 26, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-0524B 2g/20 mg Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
MK-0524B 2g/40mg Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg Atorvastatin 80 mg, orally, once daily for 12 weeks

Participant Flow:   Overall Study
    MK-0524B 2g/20 mg   MK-0524B 2g/40mg   Atorvastatin 10 mg   Atorvastatin 20 mg   Atorvastatin 40 mg   Atorvastatin 80 mg
STARTED   297   436   298   439   437   433 
Treated   297   435   298   439   437   433 
COMPLETED   229   316   265   380   392   372 
NOT COMPLETED   68   120   33   59   45   61 
Adverse Event                28                40                13                19                20                33 
Lost to Follow-up                7                7                8                8                4                8 
Participant had flushing                18                42                1                2                0                4 
Other                0                0                0                5                1                0 
Participant moved                1                0                0                1                1                1 
Withdrawal by Subject                10                21                8                18                12                11 
Protocol Violation                3                9                2                6                7                4 
site terminated                1                0                1                0                0                0 
Not treated                0                1                0                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK-0524B 2g/20 mg Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
MK-0524B 2g/40mg Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
Atorvastatin 10 mg Atorvastatin 10 mg, orally, once daily for 12 weeks
Atorvastatin 20 mg Atorvastatin 20 mg, orally, once daily for 12 weeks
Atorvastatin 40 mg Atorvastatin 40 mg, orally, once daily for 12 weeks
Atorvastatin 80 mg Atorvastatin 80 mg, orally, once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
   MK-0524B 2g/20 mg   MK-0524B 2g/40mg   Atorvastatin 10 mg   Atorvastatin 20 mg   Atorvastatin 40 mg   Atorvastatin 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 297   436   298   439   437   433   2340 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.1  (10.8)   55.0  (10.3)   53.7  (10.6)   54.8  (10.8)   55.1  (10.1)   54.7  (10.5)   54.7  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      165  55.6%      237  54.4%      169  56.7%      248  56.5%      232  53.1%      258  59.6%      1309  55.9% 
Male      132  44.4%      199  45.6%      129  43.3%      191  43.5%      205  46.9%      175  40.4%      1031  44.1% 


  Outcome Measures

1.  Primary:   Percentage Change From Baseline in the LDL-C/HDL-C Ratio   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Percentage Change From Baseline in HDL-C   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Percentage Change From Baseline in Triglycerides (TG)   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Percentage Change From Baseline in Non-HDL-C   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percentage Change From Baseline in LDL-C   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Percentage Change From Baseline in Apolipoprotein (Apo) B   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Percentage Change From Baseline in Apo A-I   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Percentage Change From Baseline in Total Cholesterol (TC)   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Percentage Change From Baseline in Lipoprotein (a) (Lp[a])   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Percentage Change From Baseline in C-reactive Protein (CRP)   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Percentage Change From Baseline in TC/HDL-C Ratio   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)   [ Time Frame: up to 12 weeks ]

13.  Secondary:   Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN   [ Time Frame: up to 12 weeks ]

14.  Secondary:   Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN   [ Time Frame: up to 12 weeks ]

15.  Secondary:   Percentage of Participants With Creatine Kinase (CK) >=10 x ULN   [ Time Frame: up to 12 weeks ]

16.  Secondary:   Percentage of Participants With CK >=10 x ULN With Muscle Symptoms   [ Time Frame: up to 12 weeks ]

17.  Secondary:   Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related   [ Time Frame: up to 12 weeks ]

18.  Secondary:   Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose   [ Time Frame: up to 12 weeks ]

19.  Secondary:   Percentage of Participants With New Diagnosis of Diabetes   [ Time Frame: up to 12 weeks ]

20.  Secondary:   Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event   [ Time Frame: up to 14 weeks ]

21.  Secondary:   Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)   [ Time Frame: up to 14 weeks ]

22.  Secondary:   Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)   [ Time Frame: up to 14 weeks ]

23.  Secondary:   Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE   [ Time Frame: up to 14 weeks ]

24.  Secondary:   Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE   [ Time Frame: up to 14 weeks ]

25.  Secondary:   Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE   [ Time Frame: up to 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289900     History of Changes
Other Study ID Numbers: 0524B-024
MK-0524B-024 ( Other Identifier: Merck Study Number )
2005_103
First Submitted: February 7, 2006
First Posted: February 10, 2006
Results First Submitted: December 17, 2015
Results First Posted: January 26, 2016
Last Update Posted: August 31, 2018