Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED) (ACHIEVE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00384293
First received: October 3, 2006
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: July 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia, Familial
Interventions: Drug: Comparator: niacin (+) laropiprant (MK0524A)
Drug: Comparator: 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
There was an MK0524A active run-in period prior to randomization. Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, for an additional 4 weeks prior to randomization.

Reporting Groups
  Description
MK0524A Active Run-In Period Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
MK0524A, 2 g (Postrandomization Period) Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
Placebo (Postrandomization Period) Patients who were randomized to placebo

Participant Flow for 2 periods

Period 1:   MK0524A Active Run-In, Pre-randomization
    MK0524A Active Run-In Period     MK0524A, 2 g (Postrandomization Period)     Placebo (Postrandomization Period)  
STARTED     937     0     0  
Entered Active run-in, MK0524A 1 g     937 [1]   0     0  
MK0524A Dose Increased to 2 g     813 [2]   0     0  
COMPLETED     433     0     0  
NOT COMPLETED     504     0     0  
Adverse Event                 120                 0                 0  
Lost to Follow-up                 1                 0                 0  
Withdrawal by Subject                 24                 0                 0  
Not cIMT eligible at Visit 3                 340                 0                 0  
Trial Termination                 16                 0                 0  
Certified Sonographer Not Available                 2                 0                 0  
Patient Unable to Complete cIMT Scan                 1                 0                 0  
[1] Entered active run-in period and received MK0524A 1 g
[2] MK0524A dose increased to 2 g in active run-in period

Period 2:   Post-randomization Period
    MK0524A Active Run-In Period     MK0524A, 2 g (Postrandomization Period)     Placebo (Postrandomization Period)  
STARTED     0     214     219  
Received ≥1 Dose of MK0524A Study Drug     0     214 [1]   218  
COMPLETED     0     0     0  
NOT COMPLETED     0     214     219  
Adverse Event                 0                 23                 7  
Lost to Follow-up                 0                 2                 1  
Protocol Violation                 0                 1                 0  
Withdrawal by Subject                 0                 8                 6  
Trial Termination                 0                 180                 204  
Patient Randomized in Error                 0                 0                 1  
[1] Received at least one dose of randomized study drug (All Patients as Treated Population)



  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
MK0524A, 2 g (Postrandomization Period) Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
Placebo (Postrandomization Period) Patients who were randomized to placebo
Total Total of all reporting groups

Baseline Measures
    MK0524A, 2 g (Postrandomization Period)     Placebo (Postrandomization Period)     Total  
Number of Participants  
[units: participants]
  214     218     432  
Age  
[units: years]
Mean ± Standard Deviation
  53.1  ± 8.94     54.5  ± 8.22     53.8  ± 8.60  
Gender  
[units: participants]
     
Female     76     82     158  
Male     138     136     274  



  Outcome Measures
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1.  Primary:   Change in Mean Carotid Intima Media Thickness   [ Time Frame: after 96 weeks of postrandomization treatment ]

2.  Secondary:   Change in Lipid Profile   [ Time Frame: after 96 weeks of postrandomization treatment ]


  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
After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not 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: NCT00384293     History of Changes
Other Study ID Numbers: 0524A-041, 2006_506
Study First Received: October 3, 2006
Results First Received: July 23, 2009
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration