Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

This study has been terminated.
(In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01274559
First received: October 25, 2010
Last updated: July 30, 2014
Last verified: July 2014
Results First Received: January 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Interventions: Drug: Extended-release niacin/laropiprant (ERN/LRPT)
Drug: Placebo

  Participant Flow
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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
Phase 3 study HPS2-THRIVE (NCT00461630) did not meet its primary endpoint of reduction of major vascular events and had a significant increase in the incidence of some types of non-fatal serious adverse events. As a result, MK-0524A-133 was discontinued. Only individual data were obtained; none of the planned efficacy outcomes were summarized.

Reporting Groups
  Description
Extended-release Niacin/Laropiprant Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Placebo Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)

Participant Flow:   Overall Study
    Extended-release Niacin/Laropiprant     Placebo  
STARTED     587     586  
Treated     572     572  
COMPLETED     390     441  
NOT COMPLETED     197     145  
Adverse Event                 57                 13  
Death                 1                 1  
Lost to Follow-up                 3                 3  
Non-compliance with Study Drug                 2                 4  
Physician Decision                 2                 1  
Protocol Violation                 28                 23  
Study Terminated by Sponsor                 79                 87  
Withdrawal by Subject                 25                 13  



  Baseline Characteristics
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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
Extended-release Niacin/Laropiprant ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Placebo Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Total Total of all reporting groups

Baseline Measures
    Extended-release Niacin/Laropiprant     Placebo     Total  
Number of Participants  
[units: participants]
  587     586     1173  
Age, Customized  
[units: Participants]
     
21 to 30 years     1     2     3  
31 to 40 years     9     12     21  
41 to 50 years     63     62     125  
51 to 60 years     182     168     350  
61 to 70 years     209     232     441  
71 to 80 years     108     98     206  
>80 years     15     12     27  
Gender  
[units: Participants]
     
Female     239     243     482  
Male     348     343     691  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Percent Change From Baseline in HDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Percent Change From Baseline in Triglyceride (TG) at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percent Change From Baseline in Non-HDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

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

7.  Secondary:   Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

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

10.  Secondary:   Percent Change From Baseline in Apo A-I at Week 12   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Percent Change From Baseline in TC at Week 12   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Percent Change From Baseline in LDL-C at Week 4   [ Time Frame: Baseline and Week 4 ]

13.  Secondary:   Percent Change From Baseline in LDL-C:HDL-C at Week 4   [ Time Frame: Baseline and Week 4 ]

14.  Secondary:   Percent Change From Baseline in HDL-C at Week 4   [ Time Frame: Baseline and Week 4 ]

15.  Secondary:   Percent Change From Baseline in TG at Week 4   [ Time Frame: Baseline and Week 4 ]

16.  Secondary:   Percent Change From Baseline in Non-HDL-C at Week 4   [ Time Frame: Baseline and Week 4 ]

17.  Secondary:   Percent Change From Baseline in Apo B at Week 4   [ Time Frame: Baseline and Week 4 ]

18.  Secondary:   Percent Change From Baseline in Apo B:Apo A-I at Week 4   [ Time Frame: Baseline and Week 4 ]

19.  Secondary:   Percent Change From Baseline in TC:HDL-C at Week 4   [ Time Frame: Baseline and Week 4 ]

20.  Secondary:   Percent Change From Baseline in Lp(a) at Week 4   [ Time Frame: Baseline and Week 4 ]

21.  Secondary:   Percent Change From Baseline in Apo A-I at Week 4   [ Time Frame: Baseline and Week 4 ]

22.  Secondary:   Percent Change From Baseline in TC at Week 4   [ Time Frame: Baseline and Week 4 ]

23.  Secondary:   Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
MK-0524A-133 was stopped prior to completion. Raw individual efficacy data were obtained but none of planned efficacy outcomes were summarized or analyzed. Only safety data were summarized.


  More Information
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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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01274559     History of Changes
Other Study ID Numbers: 0524A-133, CTRI/2012/08/002857
Study First Received: October 25, 2010
Results First Received: January 30, 2014
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration