Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents (NCT00102479) | Clinical Trial Compass
CompletedPhase 1
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
21 participantsStarted 2004-07-01
Plain-language summary
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female children and adolescents between 10 and 17 years, inclusive, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder.
* Good physical health as determined by no clinically significant deviation from normal in medical history, clinical laboratory determination, electrocardiograms (ECG) and physical examinations conducted within 14 days prior to study enrollment.
* Both the legal guardian and study subject must have signed written informed consent. Consent must have been obtained prior to any screening evaluations.
* Subjects must have had a caretaker or guardian who could adequately complete appropriate documentation required by the protocol.
Exclusion Criteria:
* Sexually active males and females who were not practicing double-barrier birth control, or who were not remaining abstinent, during the study and for 30 days (females only) or 90 days (males only) following the last dose of study medication.
* All sexually active females of childbearing potential must have had a negative serum pregnancy test with results available prior to receiving study drug.
* Breastfeeding females were excluded.
* History of recent (within 6 months) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Diagnostic Criteria for Drug and Alcohol Abuse and/or a positive urine screen for drugs of abuse.
* History of mental retardation or mental retardation asse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Able to Tolerate Maximum Dose Level
Timeframe: 14 Days
2
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
Timeframe: 57 days
3
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Timeframe: Pre-dose and 1 to 24 hours post-dose on Day 14
4
Aripiprazole Time to Maximum (Peak) Plasma Concentration (Tmax)
Timeframe: Pre-dose and 1 to 25 hours post-dose on Day 14
5
Aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Timeframe: Pre-dose and 1 to 24 hours post-dose on Day 14
Trial details
NCT IDNCT00102479
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.