Trial Outcomes & Findings for The Impact of Grapefruit Juice on the Response to Clopidogrel (NCT NCT00817999)
NCT ID: NCT00817999
Last Updated: 2012-10-01
Results Overview
% platelet inhibition measured by Verify Now
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
6 hours
Results posted on
2012-10-01
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Grapefruit Juice
STARTED
|
15
|
17
|
|
Grapefruit Juice
COMPLETED
|
15
|
17
|
|
Grapefruit Juice
NOT COMPLETED
|
0
|
0
|
|
No Grapefruit Juice
STARTED
|
15
|
17
|
|
No Grapefruit Juice
COMPLETED
|
15
|
17
|
|
No Grapefruit Juice
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Grapefruit Juice on the Response to Clopidogrel
Baseline characteristics by cohort
| Measure |
Loading Dose
n=15 Participants
|
Maintenance Dose
n=17 Participants
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
25.47 years
STANDARD_DEVIATION 5.66 • n=7 Participants
|
25.47 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours% platelet inhibition measured by Verify Now
Outcome measures
| Measure |
Loading Dose With Grapefruit Juice
n=15 Participants
|
Maintenance Dose With Grapefruit Juice
n=17 Participants
|
Loading Dose Without Grapefruit Juice
n=15 Participants
|
Maintenance Dose Without Grapefruit Juice
n=17 Participants
|
|---|---|---|---|---|
|
% Platelet Inhibition
|
23.4 percentage of platelet inhibition
Standard Deviation 14.2
|
24.6 percentage of platelet inhibition
Standard Deviation 24.2
|
41.2 percentage of platelet inhibition
Standard Deviation 19.1
|
59 percentage of platelet inhibition
Standard Deviation 22.5
|
Adverse Events
Loading Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maintenance Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place