Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

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:
NCT01414166
First received: August 9, 2011
Last updated: January 30, 2014
Last verified: January 2014
Results First Received: November 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Drug: 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
This study took place at 37 centers in 2 countries (29 sites in India and 8 sites in Philippines).

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
ERN/LPRT Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
Placebo Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.

Participant Flow:   Overall Study
    ERN/LPRT     Placebo  
STARTED     122     122  
Treated     120     121  
COMPLETED     31     39  
NOT COMPLETED     91     83  
Adverse Event                 10                 2  
Lost to Follow-up                 4                 1  
Non-compliance with study drug                 2                 0  
Physician Decision                 2                 0  
Protocol Violation                 2                 0  
Study terminated by Sponsor                 68                 75  
Withdrawal by Subject                 3                 5  



  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
ERN/LPRT Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
Placebo Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
Total Total of all reporting groups

Baseline Measures
    ERN/LPRT     Placebo     Total  
Number of Participants  
[units: participants]
  122     122     244  
Age  
[units: Years]
Mean ± Standard Deviation
  45.8  ± 9.30     45.3  ± 10.18     45.5  ± 9.73  
Gender  
[units: Participants]
     
Female     93     79     172  
Male     29     43     72  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16   [ Time Frame: Baseline and Weeks 12 to 16 ]

2.  Secondary:   Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16   [ Time Frame: Baseline and Week 16 ]

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

4.  Secondary:   Percent Change From Baseline in Triglycerides (TG) at Week 16   [ Time Frame: Baseline and Week 16 ]

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

6.  Secondary:   Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16   [ Time Frame: Baseline and Week 16 ]

7.  Secondary:   Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16   [ Time Frame: Baseline and Week 16 ]

8.  Secondary:   Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16   [ Time Frame: Baseline and Week 16 ]

9.  Secondary:   Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16   [ Time Frame: Baseline and Week 16 ]


  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
Due to the small number of participants completing the study (n=70), the resulting underpowered nature of any analyses that might be conducted, and the fact that data are not going to be used, no efficacy analyses were performed.


  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: Vice President, Late Stage Development Group Leader
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: NCT01414166     History of Changes
Other Study ID Numbers: 0524A-108, CTRI/2012/08/002873
Study First Received: August 9, 2011
Results First Received: November 21, 2013
Last Updated: January 30, 2014
Health Authority: India: Drugs Controller General of India