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The Impact of Grapefruit Juice on the Response to Clopidogrel

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ClinicalTrials.gov Identifier: NCT00817999
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition: Healthy
Interventions: Dietary Supplement: Grapefruit juice
Drug: Clopidogrel 75 mg/day
Drug: Clopidogrel 300 mg

  Participant Flow

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
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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

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00817999     History of Changes
Other Study ID Numbers: 08-15073
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: August 8, 2011
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012