Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibri… (NCT01229254) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
189 participantsStarted 2010-09
Plain-language summary
The primary purpose of this study is to optimize drug exposure in the target population.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* In the opinion of the investigator, participant requires long term anticoagulation for stroke prevention in atrial flutter (AF).
* Men and women ≥18 years of age.
* Participant has current non-valvular atrial fibrillation (NVAF) or AF or electrocardiogram (ECG) or Holter documentation within past 12 months.
* Participant has an international normalized ratio (INR) ≤ 2.2 at allocation (Visit 2).
* A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy, and hormonal contraception.
* Participant understands the study procedures and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
Exclusion Criteria:
General
* Participant is currently participating in another drug study or has received an investigational drug within 30 days prior to enrollment.
* Participant is a woman who is pregnant, lactating or of child-bearing potential who refuses to use a medically acceptable form of contraception throughout the study.
* Participant has a body weight less than 40 kg (88 lbs) or greater than 200 kg (440 lbs).
* Participant routinely consumes more than 2 alcoholic drinks per day (average \>14 alcoholic drinks per week) or greater than 5 drinks within 2 hours on occasion.
Prohibit…
What they're measuring
1
Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing