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The Impact of Grapefruit Juice on the Response to Clopidogrel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00817999
First received: January 6, 2009
Last updated: August 28, 2012
Last verified: August 2012
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Healthy
Interventions: Dietary Supplement: Grapefruit juice
Drug: Clopidogrel 75 mg/day
Drug: Clopidogrel 300 mg

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Loading Dose Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
Maintenance Dose Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.

Participant Flow for 2 periods

Period 1:   Grapefruit Juice
    Loading Dose     Maintenance Dose  
STARTED     15     17  
COMPLETED     15     17  
NOT COMPLETED     0     0  

Period 2:   No Grapefruit Juice
    Loading Dose     Maintenance Dose  
STARTED     15     17  
COMPLETED     15     17  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Loading Dose No text entered.
Maintenance Dose No text entered.
Total Total of all reporting groups

Baseline Measures
    Loading Dose     Maintenance Dose     Total  
Number of Participants  
[units: participants]
  15     17     32  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     17     32  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24.4  ± 5.9     25.47  ± 5.66     25.47  ± 5.66  
Gender  
[units: participants]
     
Female     10     13     23  
Male     5     4     9  
Region of Enrollment  
[units: participants]
     
United States     15     17     32  



  Outcome Measures

1.  Primary:   % Platelet Inhibition   [ Time Frame: 6 hours ]


  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: Tammy Burns, PharmD
Organization: Creighton University
phone: 402-280-4292
e-mail: TammyBurns@creighton.edu


No publications provided


Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00817999     History of Changes
Other Study ID Numbers: 08-15073
Study First Received: January 6, 2009
Results First Received: August 8, 2011
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board