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

History of Changes

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 ]

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Serious Adverse Events

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Other Adverse Events

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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

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

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