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Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01067339
First received: February 9, 2010
Last updated: March 22, 2017
Last verified: March 2017
Results First Received: January 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Endothelial Dysfunction
Interventions: Drug: darapladib
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
Subjects were recruited at the Mayo Clinic in Rochester, Minnesota between February 2010 and February 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
70 subjects signed informed consent, but 5 subjects withdrew (subject decision) prior to randomization.

Reporting Groups
  Description
Darapladib Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
Placebo Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.

Participant Flow:   Overall Study
    Darapladib   Placebo
STARTED   31   34 
COMPLETED   25   29 
NOT COMPLETED   6   5 
Withdrawal by Subject                6                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.
The baseline characteristics table only includes subjects who completed the study.

Reporting Groups
  Description
Darapladib Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
Placebo Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
Total Total of all reporting groups

Baseline Measures
   Darapladib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   29   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (11.7)   54.0  (10.5)   54.5  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  68.0%      26  89.7%      43  79.6% 
Male      8  32.0%      3  10.3%      11  20.4% 
Region of Enrollment 
[Units: Participants]
     
United States   25   29   54 


  Outcome Measures
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1.  Primary:   Percentage Change in Coronary Artery Diameter   [ Time Frame: baseline, six months ]

2.  Primary:   Percentage Change in Coronary Blood Flow (CBF)   [ Time Frame: baseline, six months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Amir Lerman, MD
Organization: Mayo Clinic
phone: 507-284-6429
e-mail: lerman.amir@mayo.edu



Responsible Party: Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01067339     History of Changes
Other Study ID Numbers: 10-000044
5R01HL092954 ( US NIH Grant/Contract Award Number )
5R01AG031750 ( US NIH Grant/Contract Award Number )
Study First Received: February 9, 2010
Results First Received: January 25, 2017
Last Updated: March 22, 2017