NCT00817999

Brief Summary

This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 1, 2012

Completed
Last Updated

October 1, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

January 6, 2009

Results QC Date

August 8, 2011

Last Update Submit

August 28, 2012

Conditions

Healthy

Keywords

Platelet Aggregation Inhibition

Outcome Measures

Primary Outcomes (1)

  • % Platelet Inhibition

    % platelet inhibition measured by Verify Now

    6 hours

Study Arms (2)

Loading Dose

EXPERIMENTAL

Participants received a 300 mg dose of clopidogrel with or without GFJ.

Dietary Supplement: Grapefruit juiceDrug: Clopidogrel 300 mg

Maintenance Dose

EXPERIMENTAL

Participants received clopidogrel 75 mg/day for 7 days with or without GFJ

Dietary Supplement: Grapefruit juiceDrug: Clopidogrel 75 mg/day

Interventions

Grapefruit juiceDIETARY_SUPPLEMENT

Participants received grapefruit juice during 1 of the 2 periods.

Loading DoseMaintenance Dose
Clopidogrel 75 mg/dayDRUG
Maintenance Dose
Clopidogrel 300 mgDRUG
Loading Dose

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 19-40
  • Health status confirmed by medical history and physical examination and laboratory analysis

You may not qualify if:

  • Pregnancy
  • Taking routine prescription or over-the-counter prescriptions
  • Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of study participation
  • Recently had grapefruit juice or regularly drinks grapefruit juice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton Cardiac Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Tammy Burns, PharmD
Organization
Creighton University
TammyBurns@creighton.edu
402-280-4292

Study Officials

  • Tammy Burns, PharmD

    Creighton Cardiac Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 1, 2012

Results First Posted

October 1, 2012

Record last verified: 2012-08

Locations

US(1)