Prasugrel/Clopidogrel Maintenance Dose Washout Study

PHASE4CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

May 31, 2010

Study Completion Date

June 30, 2010

Conditions
Coronary Artery Disease
Interventions
DRUG

Prasugrel

"Prasugrel 10mg tablet administered once daily for 7 days.~After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."

DRUG

Clopidogrel

"Clopidogrel 75 mg tablet administered once daily for 7 days.~After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."

Trial Locations (4)

32209

University of Florida Health Science Center Shands Jacksonville, Jacksonville

45212

Medpace Clinical Pharmacology Unit, Cincinnati

57701

Black Hills Clinical Research Center, Rapid City

92037

Scripps Clinic, La Jolla

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT01014624 - Prasugrel/Clopidogrel Maintenance Dose Washout Study | Biotech Hunter | Biotech Hunter