Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)

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:
NCT01228019
First received: October 22, 2010
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: March 25, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hypercholesterolemia
Mixed Dyslipidemia
Intervention: Drug: Niacin (+) laropiprant

  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
1,166 participants who were currently using niacin (+) laropiprant (TREDAPTIVE) for treatment of primary hypercholesterolemia or mixed dyslipidemia were enrolled and their case report forms were collected. Enrollment was stopped early due to termination of all studies involving TREDAPTIVE.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A completer was considered a participant eligible for safety population. Efficacy population was a sub-population of the safety population

Reporting Groups
  Description
All Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Participant Flow:   Overall Study
    All Participants  
STARTED     1166  
COMPLETED     862  
NOT COMPLETED     304  
Dose Violation                 70  
Duplicate enrollment                 1  
Missing pre-treatment data                 72  
Triglyceride Entry Criteria Not Met                 152  
Violation of Entry Criterion                 9  



  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.
Baseline characteristics presented for participants in the Safety Population

Reporting Groups
  Description
All Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  862  
Age  
[units: years]
Mean ± Standard Deviation
  59.03  ± 10.92  
Gender  
[units: participants]
 
Female     268  
Male     594  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Any Adverse Experience   [ Time Frame: From start of treatment through 14 days after the last dose (Up to 26 weeks) ]

2.  Primary:   Percentage of Participants With Adverse Drug Reactions   [ Time Frame: From start of treatment through 14 days after the last dose (Up to 26 weeks) ]

3.  Primary:   Change From Baseline in Total Cholesterol at Week 12   [ Time Frame: Baseline and Week 12 ]

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

5.  Primary:   Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Primary:   Change From Baseline in Triglycerides at Week 12   [ Time Frame: Baseline and Week 12 ]

7.  Primary:   Change From Baseline in Total Cholesterol at Week 24   [ Time Frame: Baseline and Week 24 ]

8.  Primary:   Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]

9.  Primary:   Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]

10.  Primary:   Change From Baseline in Triglycerides at Week 24   [ Time Frame: Baseline and Week 24 ]

11.  Primary:   Investigator's Overall Efficacy Evaluation at Week 12   [ Time Frame: Baseline and Week 12 ]

12.  Primary:   Investigator's Overall Efficacy Evaluation at Week 24   [ Time Frame: Baseline and Week 24 ]


  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
Study enrollment stopped early due to termination of all TREDAPTIVE studies. Data obtained for participants enrolled prior to termination was analyzed and reported.


  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: NCT01228019     History of Changes
Other Study ID Numbers: 0524A-119
Study First Received: October 22, 2010
Results First Received: March 25, 2014
Last Updated: March 25, 2014
Health Authority: Korea: Food and Drug Administration