DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Placebo (to match Aspirin) (Drug); Aspirin (Drug); Clopidogrel (Drug); Comparator: Placebo (to match Clopidogrel) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.

The intra-subject coefficient of variation of each of the 3 platelet function devices

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject has BMI (Body Mass Index) less than 32 kg/m^ 2

- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing

products for at least approximately 3 months

- Subject does not have a history of any bleeding disorder

Exclusion Criteria:

- Subject is a pregnant or nursing female

- Subject has a history of multiple and/or severe allergies to drugs or foods, or any

history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)

- Subject currently uses on a regular basis or has used aspirin or clopidogrel within

21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)

- Subject currently uses on a regular basis or has used within 2 weeks prior to study

start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e. g., St. John Wort)

- Subject anticipates needing during the study any prescription or nonprescription

(including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies

- Subject has a history of skin conditions (such as dry skin, pruritus, rosacea,

eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study

- Subject regularly uses antacids or other OTC medications (4 or more times per month)

for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e. g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years

- Subject has a history of poor wound healing or a tendency to form keloids

Locations and Contacts

Additional Information

Starting date: June 2010
Last updated: August 11, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017