Effectiveness of a short video-based educational intervention on factors related to clinical trial participation in adolescents and young adults: a pre-test/post-test design.

Background: Poor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities. Efforts to address barriers to enrollment have been predominantly focused on adult diseased populations. Because older adults may already have established attitudes, it is imperative to identify strategies that target adolescents and young adults.

The project IMPACT experience to date: increasing minority participation and awareness of clinical trials.

Objective: This study evaluated activities of Project IMPACT (Increase Minority Participation and Awareness of Clinical Trials), a National Medical Association (NMA) project chartered to identify ways to increase minority physician and patient involvement in clinical trials. Project IMPACT included physician education and training workshops, establishment of a physician-investigator database and other activities to facilitate minority-physician clinical trial participation.

Methods: A descriptive survey was used.

Influence of coadministration on the pharmacokinetics of azimilide dihydrochloride and digoxin.

The influence of coadministration on digoxin and azimilide pharmacokinetics/pharmacodynamics was assessed in a randomized, 3-way crossover study in 18 healthy men. Serial blood and urine samples were obtained for azimilide and digoxin quantitation. Treatment effects on pharmacokinetics were assessed using analysis of variance.

Effect of mild and moderate hepatic impairment on azimilide pharmacokinetics following single dose oral administration.

Azimilide dihydrochloride (75-125 mg/day) is currently being developed for use in prolonging the time to recurrence of atrial fibrillation/flutter and for reducing the frequency of shocks in patients with an implantable cardioverting defibrillator. This study investigated the influence of mild and moderate hepatic impairment on azimilide pharmacokinetics. Six subjects each with mild and moderate hepatic impairment (Child-Pugh grades A and B, respectively) were age, weight, smoking status, and gender-matched to a healthy subject (total N = 24).

Effect of severe renal impairment on the pharmacokinetics of azimilide following single dose oral administration.

Aims: To assess the influence of severe renal impairment on azimilide pharmacokinetics.

Methods: A single oral dose of 125 mg azimilide dihydrochloride was administered to subjects with normal and severely impaired renal function. Blood and urine samples were collected for 22-28 and 10 days, respectively.